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An integrated approach to successful eClinical trials CCRA Seminar: Standards in Electronic Data Capture London 1 Novemb

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. Presentation contents. Common application of IVR/IWR in today’s clinical trials

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An integrated approach to successful eClinical trials CCRA Seminar: Standards in Electronic Data Capture London 1 Novemb

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  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 SurveyClinPhone 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 SurveyClinPhone 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/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

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

  9. Why Integrate? The benefits of eClinical integration

  10. CTMS Safety System DSMS IVR CDMS EDC eClinical solutions

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

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

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

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

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

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

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

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

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

  22. Case studyIVR-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. EDC IVR/web IVR/web IVR/web CTMS IVR / web CTMS DSMS EDC DSMS New study site details Site contact detail amendments Regulatory / ethics approval IVR central hub of real-time data Clinical Trial Management System Clinical Trial Management System New patient enrolled / withdrawn/ completed Site medication inventories Patient tracking data 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 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 New study site / details Shipment requests

  34. For more information www.clinphone.com info@clinphone.com

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