1. An integrated approach to successful eClinical trials
CCRA Seminar: Standards in Electronic Data Capture
London 1 November 2005
Dr Bill Byrom
Product Strategy Director, ClinPhone Group Ltd.

2. 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

3. Common IVR / IWR application
Typical application areas in today’s clinical trials

4. 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

5. Recent Survey ClinPhone webinar April 2005 (n=300)
What is the largest issue or challenge you face with randomisation and blinding in today’s clinical trials?
Ensuring sites follow the randomization process correctly
Preventing tampering of code break envelopes
Providing 24h on-call code break staff
Managing more complicated randomization e.g.. stratification
Ensuring randomization methods are followed in open label studies
Demonstrating internal staff are blinded to randomization schedule
Other

6. Recent Survey ClinPhone webinar April 2005 (n=300)
What is the largest issue or challenge you face with medication management in today’s clinical trials?
Accurately forecasting the amount of drug required
Managing the logistics of large multinational trials
Managing drug expiration
Limitations on supplies due to manufacturing
Efficient use of medication in titration studies
Other

7. Medication labelling/dispensing IVR / 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
When performing medication management using an IVR or IWR approach, each pack is now uniquely numbered – packs no longer are assigned to specific subjects or to visits.
This means that any pack can be dispensed to any subject for any visit, for subjects assigned to the same treatment group.
This is most advantageous – in terms of wastage – if packs are dispensed in the smallest dispensing unit. A 1-month pack dispensed each month will result in less wastage than dispensing a 3-month pack every 3 months.
The IVR and IWR approach can also provide substantial saving in medication for protocols running simultaneously for which the same packs can be used for any of the protocols.

8. Medication dispensing and re-supply
ClinPhone Inventory
database
Notification:
Arrival /
Damaged packs
Dispensing
call
Consignment details
Consignment request
Pack numbers
Drug distribution
depot
Investigational site
Shipment A B
Stock levels fall to trigger level

9. The benefits of eClinical integration
Why Integrate?
The benefits of eClinical integration

10. eClinical solutions
EDC
IVR
CDMS
Safety
System
CTMS
DSMS

11. 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

12. 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

13. The breadth of integration Example 1: patient enrolment
EDC
IVR
CDMS
Safety
System
CTMS
DSMS
Patient Identifiers, demography and visit frequency data
Drug supply / re-supply request
Randomisation Event
Data for randomisation (eg. stratification variables)
Randomisation and Pack Number
Drug Shipment
Patient Data
Patient Enrolment

14. The breadth of integration Example 2: IVR diary call
EDC
IVR
CDMS
Safety
System
CTMS
DSMS
Tracking Primary Efficacy data
Drug re-supply request
Safety alerts
Data validation
Patient completes IVR Diary
Diary Data
Diary Data
Data validation

15. Common overlap of data IVR CTMS EDC Randomization Dispensing ePRO
Screening data
Site contact details

16. How real-time eClinical integration is achieved at ClinPhone
Integration overview
How real-time eClinical integration is achieved at ClinPhone

17. Data interchange overview
F I R E W A L L
F I R E W A L L
FTP
site
Application-specific message
format
XML message
IVR / IWR
database
Application
database
Event
Exporter
Importer
Transformer
Database update
XML message
Application-specific
Message
format
FTP
site
Application

18. IVR-CTMS Integration
EDC
IVR
CDMS
Safety
System
CTMS
DSMS

19. Integration touchpoints: CTMS
Site details
Delivery addresses
Patient number ranges
Site initiation / qualification
Site activation
FSFV (screening)
Randomisation
Re-dispensing
Withdrawal / completion
LSLV
Site / study close
Study timeline
IVR / IWR
CTMS
Ethics approval
Regulatory approval
Date first drug shipped
Patient tracking data
Patient tracking data
Patient tracking data
Patient tracking data
Patient tracking data
Site de-activation

20. IVR–EDC integration
EDC
IVR
CDMS
Safety
System
CTMS
DSMS

21. Integration Touchpoints: EDC
Site initiation / qualification
Site activation
FPFV (screening)
Randomization
Re-dispensing
Withdrawal / completion
LPLV
Site / study close
Study timeline
IVR / IWR
EDC
Initial shipment?
Subject no.
Initials / d.o.b.
Stratification data
Pack dispensed
Diary data
Pack dispensed
Withdrawal

22. Case study IVR-EDC integration
Procter and Gamble Pharmaceuticals

23. P&GP’s Best Practices entry

24. 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)

25. 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

26. 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

27. 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

28. 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

29. Demonstration movie
EDC - IVR integration

30. 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

31. Summary and conclusions

32. 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

33. Clinical Trial Management System Clinical Trial Management System
New study site details
Site contact detail amendments
Regulatory / ethics approval
IVR central hub of
real-time data
CTMS
IVR/web
Clinical Trial Management System
Clinical Trial Management System
New patient enrolled / withdrawn/ completed
Site medication inventories
Patient tracking data
IVR /
web
CTMS
EDC
DSMS
New
study
site
Patient withdrawal
Patient completion
Randomization data
Dose adjustment / calculation data
Electronic Data Capture
System
Electronic Data Capture
System
Medication
pack
dispensed
New patient enrolled
New study site
EDC
IVR/web
Randomization number
Medication pack number(s)
IVR diary data
Dispatch notification
Pack list and pack list updates
Expiry date updates
New patient enrolled
Drug Supply Chain Management
System
DSMS
New study site / details
IVR/web
Shipment requests

34. www.clinphone.com info@clinphone.com
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