CTSA Program Steering Committee January 13, 2020

2:30 – 4:00 ET

Agenda

2:30 Welcome Barry Coller

Christopher Austin

2:30 – 3:00 New Member Introductions New Member Round Robin

3:00 – 3:20 Working Group Proposals

• Cycle I Outcomes and Next Steps • Discussion: Feedback from WG applicants on process? • Working Group Proposals - Cycle II Improvements

Barry Coller

Christopher Austin

Martin Zand

3:20 – 3:30 Methods & Processes Enterprise Committee Overview John Buse

3:30 – 4:00 “Wicked” Translational Science List and Prioritization Michael Kurilla

Welcome New Steering Committee Members!

2020 – 2022 Cohort

Cynthia Morris, Ph.D., MPH

Oregon Health & Science

University

UL1 Member

Ralph Sacco, MD,

MS, FAHA, FAAN

University of Miami

UL1 Member

Ron Sokol, M.D.

University of Colorado

UL1 Member

Robert Kimberly, M.D.

University of Alabama,

Birmingham

UL1 Member

Laura James, M.D.

University of Arkansas

UL1 Member

Miriam Bredella, M.D.

Harvard University

KL2 Member

Wayne McCormack Ph.D

University of Florida

TL1 Member

Barry Coller

Working Group Proposals: Cycle I Decisions

Cycle I - Working Group Proposal Outcomes and Next Steps

• 9 proposals were submitted

• 4 proposals were approved by the SC to move forward:• Enterprise Data Warehouse for Research – Phase 2 WG

• Inclusion of Older Adults as a Model for Special Populations Working Group

• Life Course Visual Toolkit Development

• Text Analytics Toward Semantic Interoperability and Data Sharing

• 5 proposals not approved to proceed have been invited to have calls with NCATS to receive feedback

• High-level feedback provided to applicant

• Two pathways:• Discussion Forum

• Reapply for the next working group receipt date

Christopher Austin

Discussion:

Have any of the SC members heard or received feedback

from WG applicants on the Cycle I process?

Working Group ProposalsCycle II ImprovementsMartin Zand, M.D., PhD

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.

Cycle II Application Improvements

1. In response to SC request to know previous activity of a group.

2. In response to the request to easily identify the authors.

SC Cycle II Review Timeline

SC Meeting and Final Decisions

3/9/2020

Preliminary Results Live

3/2/2020

SC Real Time Discussion and

Review Process

2/10/2020 –3/1/2020

Approved WGs will go live 4/1/2020

Proposal Submission Deadline: 1/31/2020

Realtime discussions on each proposal

Preliminary anonymous review process

Methods & ProcessEnterprise Committee

John Buse, MD, PhD

NC Translational and Clinical Sciences Institute

University of North Carolina

Chapel Hill, NC

jbuse@med.unc.edu

Goal/Focus

Goal: The scientific study of the process of conducting translational science itself enables significant advances in translation

This Enterprise Committee focuses on:

• Enabling CTSA programs to function individually and together as a research engine transforming the way translational science is conducted across the nation to make tangible improvements in the health of individuals and the population.

• Rapidly translating CTSA-generated new knowledge and technologies into health interventions in real world settings

• Developing technologies, methods, data, analytics and resources that change the way translational scientists approach their work.

• Generating and curating comprehensive data sets or other resources that catalyze science

https://clic-ctsa.org/groups/methods-processes-enterprise-committee

Lead Team

• 2019: • Brad Pollock University of California,

Davis - Chair

• George Mashour University of Michigan - Co-Chair (SC)

• Willard Dere University of Utah

• John Buse University Of North Carolina Chapel Hill

• Don McClain Wake Forest University Health Sciences

• Timothy Hsiao NCATS

• 2020: • Willard Dere University of Utah

• John Buse University Of North Carolina Chapel Hill

• Jihad Obeid Medical University of South Carolina

• Scott Steele University of Rochester

• Timothy Hsiao NCATS

https://clic-ctsa.org/groups/methods-processes-enterprise-committee

Prior art

• Developing Translational Science Team Competencies

• Institutional Readiness for Team Science

• Regulatory Science to Advance Precision Medicine

• Designing and Analyzing Clinical Trials for Personalized Medicine

• EMR-based Research Recruitment

https://clic-ctsa.org/groups/methods-processes-enterprise-committee

New vision

• The Steering Committee would be the primary source for generating topics related to Methods & Processes that are of critical interest to the CTSA consortium.

• The Enterprise Committee will serve as a group of experts who are the investigative and effector arm in exploring priority roadblocks and opportunities in translational science.

• The CTSA consortium will create a cycle of topic generation, prioritization by SC, action by EC followed by distribution, testing and refinement.

https://clic-ctsa.org/groups/methods-processes-enterprise-committee

Michael Kurilla

“Wicked” Translational Science List and Prioritization

Background

• Objective: Select up to 2 high-impact SC projects that advance the field of translational science and makes an impact within the CTSA Program

• Pod exercise conducted from November – December 31, 2019

• 3 pods responded to the exercise

• 1 response was from the translational science opportunities breakout room from the Sept. CTSA Program Meeting

• No specific criteria, focus or themes were requested• “Think about urgent high-impact translational science issues that the CTSA Program

Steering Committee can work on.”

• Co-Chairs reviewed data last week

Proposed Process

Task Date

SC receive data and review proposed project ideas and themes January 17, 2020

SC discuss submitted ideas on next SC call February 10, 2020

SC rates projects ideas. Ratings to be submitted to CLIC by February 28, 2020

Ratings will be tallied with weighted criteria set by the SC Co-Chairs March 1, 2020

Ratings will be presented at the March call for discussion March 9, 2020

Objective: Prioritize submitted topics and conduct an objective and systematic review for selection

Today’s objective: Review criteria for project selection

Process

SC to rate project ideas on the following criteria:

• Enhance translational efficiency

• Impact on the CTSA Program AND the field of translational science

• Feasibility

• Ethically important

• Regulatory importance

• Unique to the CTSA SC charge (that is, no one else will do it)

• Public health significance

Will impact the CTSA

and within locus of control

Data sharing

Big data to alter practice/diagnosis

Use of multiple datasets

Access to resources to address labor intensive activities

Privacy and data protection for research

Removing institutional bottlenecks -sharing of resources

Evaluating the impact of translational research efforts

Implementing Scientific Review before Studies are Performed

Will Impact CTSA, but goes

beyond purview of the CTSA SC

Validity and quality of EHR

NIH Data Sharing Policy

Clinical trial design (Pilot to Funding)

Access to unrepresented populations

Too broad an issue and/or not

within the purview of the CTSA SC

Communication of emerging problems in the national research enterprise to faculty investigatorsCTSA Institutions Selling (Licensing) Their De-Identified EMR Data to Technology CompaniesGenotyping people in research studies and adverse findings.EU Citizens in our EMRs and GDPR

Destructive health-related human behaviors

Reverse Translation

Phase III Trial

Current Organization of Ideas Process

Next Meeting:

February 10, 20202:30 – 4:00 ET