ctsa program steering committee meetingnode:type... · collaborative innovation awards to u01 and...
TRANSCRIPT
CTSA Program Steering Committee Meeting
April 14 2020
Agenda
Objective A structured discussion on how CTSA resources tools andor processes can be utilized by the CTSA
consortium in the race to study and better understand COVID-19
100 Welcome Barry Coller Christopher Austin
105 ndash 120 CTSA Program and NCATS Updates Michael Kurilla Christopher Austin
120 ndash 205 COVID Activities Overview and Discussion Moderated by Barry Coller
205 ndash 250 Clinical Trial Resources Trial Innovation Network Activities Dan Ford Jane Atkinson
250 ndash 350 Creating a Clinical Evidence Data Platform for COVID-19 Joni Rutter Melissa Haendel
350 ndash 400 Center for Leading Innovation amp Collaboration (CLIC) Martin Zand
(If time allows)
400 Adjourn
CTSA Program Updates
Michael Kurilla MD PhD Director Division of Clinical Innovation
Notice of Special Interest Clinical and Translational Science Award (CTSA) Program Administrative Supplements
(NOT-TR-20-014)
Add dedicated quality assurancequality control position to perform quality reviews of CTSA-related submissions to NCATS submissions to the eRAHuman Subjects System and management of the overall process
bull Administrative Supplements to UL1 awards (through PA-18-591)
bull Due Date May 4 2020 (and onwards)
bull Budget request limited to salary fringe FampA for one dedicated quality assurancequality control position
bull Questions contact your Program Officer
Notice of Special Interest CTSA Program Applications to Address COVID-19 Public Health Need (NOT-TR-20-011)
Particular interest in projects focusing on the use of informatics solutions to diagnose cases and the use of CTSA-supported core resources (eg advanced scientific instruments highly-specialized facilities and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics therapeutics and vaccines
Administrative Supplements to UL1 U01 and R21 awards (thru PA-18-591)
Collaborative Innovation Awards to U01 and R21 awards (thru PAR-19-099 amp PAR-19-100)
Competitive Revisions for UL1 awards for each of the non-administrative supplement awards (thru PAR-19-337)
Pending updates
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Agenda
Objective A structured discussion on how CTSA resources tools andor processes can be utilized by the CTSA
consortium in the race to study and better understand COVID-19
100 Welcome Barry Coller Christopher Austin
105 ndash 120 CTSA Program and NCATS Updates Michael Kurilla Christopher Austin
120 ndash 205 COVID Activities Overview and Discussion Moderated by Barry Coller
205 ndash 250 Clinical Trial Resources Trial Innovation Network Activities Dan Ford Jane Atkinson
250 ndash 350 Creating a Clinical Evidence Data Platform for COVID-19 Joni Rutter Melissa Haendel
350 ndash 400 Center for Leading Innovation amp Collaboration (CLIC) Martin Zand
(If time allows)
400 Adjourn
CTSA Program Updates
Michael Kurilla MD PhD Director Division of Clinical Innovation
Notice of Special Interest Clinical and Translational Science Award (CTSA) Program Administrative Supplements
(NOT-TR-20-014)
Add dedicated quality assurancequality control position to perform quality reviews of CTSA-related submissions to NCATS submissions to the eRAHuman Subjects System and management of the overall process
bull Administrative Supplements to UL1 awards (through PA-18-591)
bull Due Date May 4 2020 (and onwards)
bull Budget request limited to salary fringe FampA for one dedicated quality assurancequality control position
bull Questions contact your Program Officer
Notice of Special Interest CTSA Program Applications to Address COVID-19 Public Health Need (NOT-TR-20-011)
Particular interest in projects focusing on the use of informatics solutions to diagnose cases and the use of CTSA-supported core resources (eg advanced scientific instruments highly-specialized facilities and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics therapeutics and vaccines
Administrative Supplements to UL1 U01 and R21 awards (thru PA-18-591)
Collaborative Innovation Awards to U01 and R21 awards (thru PAR-19-099 amp PAR-19-100)
Competitive Revisions for UL1 awards for each of the non-administrative supplement awards (thru PAR-19-337)
Pending updates
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
CTSA Program Updates
Michael Kurilla MD PhD Director Division of Clinical Innovation
Notice of Special Interest Clinical and Translational Science Award (CTSA) Program Administrative Supplements
(NOT-TR-20-014)
Add dedicated quality assurancequality control position to perform quality reviews of CTSA-related submissions to NCATS submissions to the eRAHuman Subjects System and management of the overall process
bull Administrative Supplements to UL1 awards (through PA-18-591)
bull Due Date May 4 2020 (and onwards)
bull Budget request limited to salary fringe FampA for one dedicated quality assurancequality control position
bull Questions contact your Program Officer
Notice of Special Interest CTSA Program Applications to Address COVID-19 Public Health Need (NOT-TR-20-011)
Particular interest in projects focusing on the use of informatics solutions to diagnose cases and the use of CTSA-supported core resources (eg advanced scientific instruments highly-specialized facilities and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics therapeutics and vaccines
Administrative Supplements to UL1 U01 and R21 awards (thru PA-18-591)
Collaborative Innovation Awards to U01 and R21 awards (thru PAR-19-099 amp PAR-19-100)
Competitive Revisions for UL1 awards for each of the non-administrative supplement awards (thru PAR-19-337)
Pending updates
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Notice of Special Interest Clinical and Translational Science Award (CTSA) Program Administrative Supplements
(NOT-TR-20-014)
Add dedicated quality assurancequality control position to perform quality reviews of CTSA-related submissions to NCATS submissions to the eRAHuman Subjects System and management of the overall process
bull Administrative Supplements to UL1 awards (through PA-18-591)
bull Due Date May 4 2020 (and onwards)
bull Budget request limited to salary fringe FampA for one dedicated quality assurancequality control position
bull Questions contact your Program Officer
Notice of Special Interest CTSA Program Applications to Address COVID-19 Public Health Need (NOT-TR-20-011)
Particular interest in projects focusing on the use of informatics solutions to diagnose cases and the use of CTSA-supported core resources (eg advanced scientific instruments highly-specialized facilities and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics therapeutics and vaccines
Administrative Supplements to UL1 U01 and R21 awards (thru PA-18-591)
Collaborative Innovation Awards to U01 and R21 awards (thru PAR-19-099 amp PAR-19-100)
Competitive Revisions for UL1 awards for each of the non-administrative supplement awards (thru PAR-19-337)
Pending updates
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Notice of Special Interest CTSA Program Applications to Address COVID-19 Public Health Need (NOT-TR-20-011)
Particular interest in projects focusing on the use of informatics solutions to diagnose cases and the use of CTSA-supported core resources (eg advanced scientific instruments highly-specialized facilities and regulatory expertise) to facilitate research on COVID-19 and advance the translation of research findings into diagnostics therapeutics and vaccines
Administrative Supplements to UL1 U01 and R21 awards (thru PA-18-591)
Collaborative Innovation Awards to U01 and R21 awards (thru PAR-19-099 amp PAR-19-100)
Competitive Revisions for UL1 awards for each of the non-administrative supplement awards (thru PAR-19-337)
Pending updates
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
CTSA Program COVID Response
bull CTSA Program Consortium Discussion Forum (initiated March 11 2020)
bull Forum for asynchronous communications about activities and collaborations
bull Collaboration between CTSA Program TIN CD2H and CLICbull Common clinical platform for communication and dissemination
bull Involved in numerous clinical activitiesbull Clinical trials (many)
bull Observational studies
bull Creating a common clinical database
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Demonstrating the Value of the NCATS CTSA Program
The current public health emergency has accelerated the merging of two interests
bull NCATSrsquo (and hubsrsquo) desire to demonstrate Program Impact
bull Hubsrsquo desire to decreasestreamline required CM activities which has become an acute issue
FY20 focus
bull Common Metrics Initiativeo Modify expectations for current CMI activities
o Communicate the successes of the CMI and dissemination of best practices
o Transition collection and analysis of hub-level metrics to the hubs
bull Data to Demonstrate Impact (D2DI) Initiate new program
bull Document COVID-19 response and accomplishments
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Common Metrics Initiative FY20 Modifications
CM Plan
Informatics Modified reporting timelineexpectations under development
Careers in Clinical amp Translational
Research
Modified reporting timelineexpectations under development
Median Accrual (expanded pilot) Modified reporting timelineexpectations under development
Median IRB Review Duration Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
Pilot Funding Publications and
(Optional) Subsequent Funding
Halt reporting of the following Common Metrics and
associated Turn the Curve Plans effective immediately (sites
are free to collect andor develop TTC plans and use for hub
operations and continuous quality improvement planning)
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
New Program Data to Demonstrate Impact (D2DI)
bull Begin to identify CTSA Program consortium-level metrics
bull Measure the impact to improve the translational research process
bull Explore new methodologies
bull Leverage mixed methods analysis which includes quantitative and qualitative measures to demonstrate impact
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Capture the Impact of the CTSA Program in Addressing the COVID-19 Public Health Need
bull Focus the collection of the CTSA Program impacts on addressing COVID-19 as an example of how the program prepares and responds to a public health crisis
bull Report format under development
bull Completionsubmission perhaps initial version due in 6 months are so update in 12 months
bull Note Emergency COVID funds may require specific reporting requirements
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
ncats_nih_gov ncatsnihgovncatsnihgov NIH-NCATS
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
NCATS Update
Christopher P Austin MD
NCATS Director
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
COVID Activities Overview and Open Discussion
Moderated by Barry Coller MDCTSA Program Steering Committee Co-Chair
Rockefeller University
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
NCATS Coordinating Centers COVID-19 Discussions ndash TIN
Update
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
TIN Trans-CC Action Itemsbull Enhance Rochesterrsquos REDCap form to collect info on trials
(noted possibilities for collection info about CT networks protocols data dictionaries for data harmonization)
bull Agreement to use one platformwidget the TINrsquosndashhttpscovidtrialstodayorgbull Finalized form will populate information into this platformwidget
bull Communication Plan ndashbull Leverage TIN Liaisons and PIs to mobilize CTSAs to populate the
form and platform Use TIN Liaisons to obtain research capacity information
bull Webinar dissemination ndash tasked to CLIC and CD2H Communication POCs
bull Other opportunities to advertise andor engagebull TIN to provide education and other resources on how to conduct CTs
effectively
bull TIN can be a resource for consultations for CTs (design discussions)
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
TIN Support for All Covid-19 Studies
bull eConsent module in REDCapbull Allows consenting remotely with multiple ways to avoid patient
contact (touchless consent)bull See webinar at httpstrialinnovationnetworkorgwp-
contentuploads202003REDCap-eConsent-and-Part-11-Validationmp4d
bull Single IRB assistance (review andor coordination)
bull Design support while primarily for multi-center studies will be considered for single center trials with high therapeutic potential
bull Recruitment and retention support
bull Rapid communication to CTSA sites via the CTSA liaison structure already demonstrated last week with data request
bull DSMB support being discussed ndash perhaps harmonizing DSMB reports
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Vanderbilt CTSA TIC RIC ORCHID trial
bull Originally planned as a single site study at Vanderbilt Study PI is located in Vanderbilt
bull Approached the NHLBI-sponsored Prevention and Early Treatment of Acute Lung Injury (PETAL) network for support and implementation The study was rapidly approved
bull Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID) is a multi-center blinded randomized controlled clinical trial to test the safety and efficacy of hydroxychloroquine as a treatment option for COVID-19 ORCHID is coordinated through PETAL whose average time from protocol initiation to patient enrollment is 12-18 months however Vanderbilt was able to open as the first enrolling site in this trial in only 13 days and since opening on April 2nd Vanderbilt has enrolled 13 participants
bull Received very early and crucial support from the Vanderbilt CTSA the TIC and the RIC during its two-week gestation to transition to the PETAL network coordinating center
bull Frank Harrell Professor of Biostatistics has been instrumental in the novel approach to the analysis plan (listen to last weekrsquos Collaboratory Grand Rounds at httpsrethinkingclinicaltrialsorggrand-rounds-hub) He and his biostatistics team contributed significantly to the development of a progressive Bayesian adaptive statistical design for this trial which includes early stopping rules in the case of harm or efficacy
bull Vanderbilt created and tested an interactive and compliant REDCap study database that will be used for data capture at all ORCHID sites
bull The Vanderbilt TIC Single IRB approved the protocol in less than two weeks
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Utah Studiesbull Hydroxychloroquine vs Azithromycin for Outpatients in Utah With
COVID-19 (HyAzOUT) bull This study will compare hydroxychloroquine and azithromycin to
determine if hydroxychloroquine is superior to azithromycin in preventing hospitalization in 1550 outpatients with suspected or confirmed COVID-19 Hospitalization within 14 days of enrollment is the primary outcome
bull Hydroxychloroquine (HCQ) versus placebo for adults ge18 years who are nucleic acid positive for COVID virus The primary outcome is viral shedding Participants will self-swab daily for 14 days and on day 28 Secondary outcome is hospitalization within 14 days N = 200 in each arm (total 400)
bull Trials designed and launched in about two weeks time
bull Utah TIC SIRB approved one trial in about two weeks
bull Utah TIC and other TIN institutions providing coordination FDA assistance DSMB support and input on the protocols
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Johns Hopkins University TICbull Planning a suite of trials to determine the therapeutic
benefit of convalescent plasma
bull Example Convalescent Plasma to Stem Coronavirus A Randomized blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs control (SARS-CoV-2 non-immune plasma) among Adults Exposed to COVID-19
bull This randomized blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria) Adults 18 years of age and older with high risk exposure and at higher risk for severe illness may participate A total of 150 eligible subjects will be randomized in a 11 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma)
bull Plan to enroll 150 participants at a minimum of 4 sites
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
COVID Research Collaboration Proposal (CRCP) Pooled Analyses
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Trial Innovation Network
PI Elizabeth Ogburn PhDInstitutionCTSA Johns Hopkins UniversityStudy Title COVID Research Collaboration Platform (CRCP) Proposal Pooled AnalysisCollaborating Partner(s) multiple TIN and CTSA Statisticians Brief Description of the Proposal Rationale No platform currently exists in the US for sharing protocols and combining data analyses Proposal Utilize a shared platform for trial design and analysisData will be collected from a select group of over 300 current COVID-19 therapeutic trials on ClinicalTrialsgov Duration 2 ndash 3 years
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Trial Innovation Network
Additional information
1) Pooled analysis of comparable investigations can lead to increased power of observations about COVID-19 infection and response to therapy
2) TIN can provide a platform for protocol sharing development and pooled analysis
3) Provides the opportunity to harmonize and incorporate data from individual CTSA sites via CLIC and TIN
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Creating a National COVID-19 Resource
Joni Rutter PhD
NCATS Deputy Director
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Building the COVID-19 Data Warehouse
bull Rapid collection of clinical laboratory and diagnostic data from hospitals and healthcare plans at the peak of the pandemic and as the pandemic evolves to understand COVID-19
bull Critical design elementsbull Speed is critical Need to collect data now before the pandemic abates
bull Make access to the data fast and easy and do not prescribe the analysisbull As data models are developed testvalidate with on-going data collection
bull Evolve to support clinical trials
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
ML algorithms (diagnosis triage predictive etc) Best practices for resource allocation Drug discovery Reduced disease severity Coordinate our efforts to maximize efficiency
All these things require the creation of a comprehensive clinical data set ndash One that the CTSA
hubs can help create
This pandemic highlights urgent needs
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Project Overview
Data Ingest Harmonized
covid data
Clinical institutional
partners
Qualified researchers
clinicians amp data contributors
Data Access Committee
Open
covid
data
Central IRB
DUA
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Distributed clinical data network advantages
Federated Data Model
The results are aggregated
Questions are sent to
network Data PartnersAggregate answers are
sent back
Distributed model
advantages
Maximizes records
Flexibility in diversity of
querying
More complete
longitudinal data
Data resides locally
Is drug X beneficial to covid-19 patients
Does Disease Y impair course
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Centralized harmonized COVID-19 dataset
advantages
Shared harmonized Covid data
N3C cloud
Centralized model advantages
Large dataset
Consistency
Improved ML applications amp analytics over
patient-level data
Shared compute infrastructure and application
deployment
Purpose-driven curationdata modeling for
covid-19
Through ML
What drugs help covid-19 patients
and which hinder
What Diagnoses impact outcome
What Social Determinants impact
course and outcome
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Modeled by
Funded byCoordinated by
CTSA Network
Patients cared for within the CTSA network
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Questions for Discussion
bull How can we start small to show proof of principle
bull Thinking about the COVID response where are the strategic places we should go first
bull What is going to prevent this vision from being fully realized
bull How can we make this successful
bull Are there technical issues NCATS needs to know about
bull What do we need to anticipate
bull What can the hubs offer
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Center for Leading Innovation amp CollaborationCTSA Program Spring Steering Committee Meeting
April 14 2020
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) Grant U24TR002260
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
CTSA Coordinating Centers amp NCATS Discussions
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
Identify and Respond to Needs
1 Discussion Forum
2 Streamlined one-stop place for information
3 Encourage collaborations amp increase visibility of active COVID studies trials visible
4 Coordinate reuse of Case Report Formsinstruments
5 Communication
35
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
1 CTSA Program COVID-19 Discussion Forum
bull Members As of April 11 ndash 98 (49 organizations)bull 26 different threads
bull Most activebull Guidance for Clinical Trials during COVID-19 Pandemic
bull Hub Activities Non-clinical
bull Wellbeing
bull Also Education and Career Development Discussion Forumbull Impact of COVID-19 on Training and Career Development
bull Sharing of approachesbull Ex The Georgia CTSA shared its SOPs for fast tracking approvals which allowed for the first
COVID-19 patient at Emory Healthcare to receive infusion therapy in just 48 hours
36
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
2 Streamlined one-stop place for information
Collaborate and Share Information
NCATS and CLIC are partnering resources to facilitate discussions around COVID-
19 Specific research or translational discussions should use the CTSA Program
Response to COVID-19 Discussion Forum to discuss and identify efforts to manage the
Coronavirus outbreak Learn more about how to join a Discussion Forum and join in
on the conversation on COVID-19 You can also view the NCATS Getting
Started resource for using the DF
Please share your hubsrsquo events news educational content and other resources about
COVID-19 by posting them on the CLIC website using the tag COVID-19 View all
posted hub information about COVID-19 on the COVID-19 tag page For
information on how to share content please check out the CLIC Library video
on Sharing Content We have provided a comment section below for short inter-
consortium communications about hub efforts around COVID-19
Specific Funding Opportunities
Current NIH Funding Opportunities Specific to COVID-19 can
be found on the NIH Information for NIH Applicants and
Recipients of NIH Funding specific to COVID-19 Also
consider applying to the CLIC Synergy Paper RFA Learn
more about Synergy Papers and review the open RFA
Clinical Trials
For the latest information about currently recruiting COVID-
19 related Clinical Trials please visit the COVID-19 Clinical
Trials feed This is a curated list from clinicaltrialsgov To
see or make others aware your specific hub research
information complete this form
bull ldquothe CLIC COVID-19 webpage is the place to point people for
consortium activities related to COVID-19rdquo - NCATS
httpsclic-ctsaorgcovid-19 37
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
3 Encourage collaborations amp increase visibility of active COVID studies trials
38
Visibility of COVID Trials
bull TIN CD2H and CLIC sharing the
Trials Today widget to disseminate
COVID trials across their websites
bull Possible use on CTSA Hubs
bull Will include preview of trials in
development (see next slide)
covidcd2horg
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
39
bull Page where consortium can go to see or make others aware your
specific hub research information complete this form
bull Easily viewable on the CLIC TIN and
CD2H websites
bull Can be completed in 5 minutes
bull Allows for updating notifications
39
3 Encourage collaborations amp increase visibility of active COVID studies trials
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
40
Many intaketriage Case Report Forms (CRFs)
being used
bull CTSA drafted amp national and international
resources ndash possibility for alignment
bull Improve interoperability with other standards
such as CDISC amp GA4GH
bull Enhance interoperability with EHRs and data
sharing
40
4 Coordinate reuse of Case Report Formsinstruments
Available on covidcd2horg
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
5 Communication
CLIC websitebull 25 Consortium News Stories submitted
bull 6 Resource educational content
bull 5 Events
bull 4 RFArsquos
Provide a place for hubs to display information about clinical research efforts happening at their hub
bull Opportunities for collaboration
bull Increase patient recruitment
bull Convey response to pandemic
31220 - 4102041
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
COVID-19 Resources
bull Identify Clinical Trials
bull Learn Outbreak Information
bull Search for Resources
bull Information about the N3C Effort
5 Communication
CD2H COVID Website covidcd2horg
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series
5 Communication
Collaboration between CD2H TIN CLIC and AMIA for webinar series