an integrated approach to successful eclinical trials ccra seminar: standards in electronic data...
TRANSCRIPT
An integrated approach to successful eClinical trials
CCRA Seminar: Standards in Electronic Data CaptureLondon 1 November 2005
Dr Bill ByromProduct Strategy Director, ClinPhone Group Ltd.
Presentation contents
Common application of IVR/IWR in today’s clinical trials
Why integrate EDC and IVR?
Integration overview
Case study: Procter & Gamble Pharmaceuticals
Demonstration movie
Conclusions
Common IVR / IWR application
Typical application areas in today’s clinical
trials
IVR/IWR application
Secure telephone / web access for the performance of
various site-based, sponsor-based, or patient-based
activities.
– Randomization
– Emergency Code Break
– Medication Dispensing and Supply Chain
Management
– Electronic Patient-Reported Outcomes (ePRO)
– Patient Pre-qualification and Recruitment
Recent SurveyClinPhone webinar April 2005 (n=300)
35%
0%
1%
52%
1%
6%
5%
0% 20% 40% 60% 80%
a) Ensuring sites follow the randomization process correctly
b) Preventing tampering of code break envelopes
c) Providing 24h on-call code break staff
d) Managing more complicated randomization e.g.. stratification
e) Ensuring randomization methods are followed in open label studies
f) Demonstrating internal staff are blinded to randomization schedule
g) Other
What is the largest issue or challenge you face with randomisation and blinding in today’s clinical trials?
Recent SurveyClinPhone webinar April 2005 (n=300)
What is the largest issue or challenge you face with medication management in today’s clinical trials?
23%
55%
9%
10%
3%
0%
0% 20% 40% 60% 80%
a) Accurately forecasting the amount of drug required
b) Managing the logistics of large multinational trials
c) Managing drug expiration
d) Limitations on supplies due to manufacturing
e) Efficient use of medication in titration studies
f) Other
Medication labelling/dispensingIVR / IWR approach
Unique Medication Numbering
– Can be applied to ‘Kit’ of supplies
– Can be applied to the Individual Dispensing Unit
Any unit can go to any patient(randomised to same treatment group)
Any unit can be used for any treatment period
Using the smallest dispensing unit gives the most flexibility
Pooling medication across studies possible
Medication dispensing and re-supply
Notification:Arrival /Damaged packs
Consignment request
Consignment details
Shipment
Dispensing call
Pack numbers
Stock levels fall to trigger
level
Investigational site
Drug distribution depot
ClinPhone Inventory database
A B
Why Integrate?
The benefits of eClinical integration
eClinical solutions
EDC
IVR
CDMS
Safety System
CTMS
DSMS
Why Integrate?
Remove duplication of data and activities
Ensure all systems contain the most up-to-date
information at all times
Simplify processes for the end-user
Enhanced data access
– Facilitate reporting and consolidation of project
management data through the solution of choice
Eliminate manual processes
Integration principles
The main objectives of any integrations:
– Do each task once – remove resource duplication
and the errors introduced by transcription
– Do it in the place that makes sense – decide on the
best overall process and configure systems to fit
– Study specific
The breadth of integrationExample 1: patient enrolment
EDC
IVR
CDMS
Safety System
CTMS
DSMS
Patient Enrolment
Data for randomisation (eg. stratification
variables)
Randomisation and Pack Number
Randomisation Event
Drug supply / re-supply
request
Drug Shipment
Patient Identifiers, demography and
visit frequency data
Patient Data
The breadth of integrationExample 2: IVR diary call
EDC
IVR
CDMS
Safety System
CTMS
DSMS
Patient completes IVR
Diary
Diary Data
Diary Data
Data validation
Data validation
Drug re-supply request
Tracking Primary Efficacy data
Safety alerts
Common overlap of data
IVR
CTMS EDC
ePRO
Randomization
Dispensing
Site contact details
Screening data
Integration overview
How real-time eClinical integration is
achieved at ClinPhone
Application-specific
message format
Application-specific Message
format
Exporter
ImporterTransformerIVR / IWR
databaseApplication
database
F
I
R
E
W
A
L
L
EventXML
message
XML message
Database update
F
I
R
E
W
A
L
L
FTP site
FTPsite
Data interchange overview
Application
IVR-CTMS Integration
EDC
IVR
CDMS
Safety System
CTMS
DSMS
Site de-activation
Ethics approvalRegulatory approval
Patient tracking data
Patient tracking data
Patient tracking data
Patient tracking data
Patient tracking data
Date first drug shipped
Site detailsDelivery addressesPatient number ranges
Integration touchpoints: CTMS
Site initiation / qualification
Site activation
FSFV (screening)
Randomisation
Re-dispensing
Withdrawal / completion
LSLV
Site / study close
Study timelineIVR / IWR CTMS
IVR–EDC integration
EDC
IVR
CDMS
Safety System
CTMS
DSMS
Diary data
Withdrawal
Subject no.Initials / d.o.b.Stratification data
Pack dispensed
Pack dispensed
Integration Touchpoints: EDC
Site initiation / qualification
Site activation
FPFV (screening)
Randomization
Re-dispensing
Withdrawal / completion
LPLV
Site / study close
Study timelineIVR / IWR EDC
Initial shipment?
Case studyIVR-EDC integration
Procter and Gamble Pharmaceuticals
P&GP’s Best Practices entry
Case study overview
Two almost identical study protocols
– IDDM and NIDDM
Sites
– USA only
– 17 sites
Patients
– 180 across both studies
IVR application (ClinPhone)
– Real-time activities whilst with patient
– Randomisation
– Medication dispensing
– Medication supply chain management
– Patient reported outcomes data collection (am and pm diary)
EDC application (Phase Forward’s InForm)
Integration objective 1
Manage 6 common data points between systems
– Patient demographic information
– Date of birth
– Initials
– Gender
– IVR generated data
– Randomisation number
– Randomisation date
– Randomisation time
Integration objective 2
Remove duplication in end-user activities
– Following randomisation call via IVR
– Pass data to InForm
– Enrol an new subject within InForm
– Populate screening and randomisation
eCRFs with IVR delivered data
Integration objective 3
Populate eCRFs with patient diary data in real-time
– AM fasting blood glucose reading
– PM sum of three daily dosing insulin volumes
Eliminate site data entry of paper diary data
Satisfy regulatory requirements for Investigators to take
responsibility for diary data
– Monitor diary compliance in real-time
– Review and report diary data alongside other
clinical data
P&GP key benefits realised
Site coordinators have less data entry to perform
The P&GP data management group do not have to check for
discrepancies between common data points in the IVR and
EDC systems
Queries from discrepancies are eliminated
– Time and financial benefit for Sponsor and site staff
Patient diary compliance proactively monitored
Investigators have immediate access to diary data via EDC
– Regulatory requirements
– Improvements in patient care and monitoring
More efficient workflow
– May improve database lock time
Demonstration movie
EDC - IVR integration
Integration example
Screening data entered within EDC application
Randomization performed using IWR
Data received by EDC
Patient diary event sent from IVR / IWR to EDC
Play movie
Summary and conclusions
The Future of Clinical Trials
A multitude of eClinical technologies are in use today
– All are being used in some trials
– Some are tightly integrated with others
– Others still used in isolation
Integration can provide powerful Sponsor and site end-
user benefits
eClinical Trials of the future?
– Evolution … not Revolution
– Increased adoption will lead to increased
requirement to integrate
– Highly integrated “seamless” solutions
Clinical Trial Management
System
Clinical Trial Management
System
Electronic Data Capture System
Electronic Data Capture System
Drug Supply Chain Management
System
CTMS IVR/web
New study site detailsSite contact detail amendmentsRegulatory / ethics approval
New patient enrolled / withdrawn/ completedSite medication inventoriesPatient tracking data
EDC IVR/web
New patient enrolledNew study site
Patient withdrawalPatient completionRandomization dataDose adjustment / calculation data
Randomization numberMedication pack number(s)IVR diary data
DSMS IVR/web
Dispatch notificationPack list and pack list updatesExpiry date updates
Shipment requests
New study site / details
Newstudysite
New patient enrolled
IVR /web
CTMS
EDC DSMS
Medication pack dispensed
IVR central hub ofreal-time data
