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2012 DIA eSource monitor-site-sponsor relationship


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This presentation discusses some of the unique impacts on the clinical trial process for Monitors, Sites, and Sponsors as they adopt electronic source records.

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2012 DIA eSource monitor-site-sponsor relationship

  1. 1. eSource: Changing theMonitor / Site / SponsorRelationshipEdward S. SeguineCEOClinical Ink
  2. 2. Disclaimer• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 2
  3. 3. Discussion Points• What is eSource?• Industry Metrics• Business Model ImplicationsAudience Participation REQUIRED
  4. 4. Vote via Texting 22333 22333 176644
  5. 5. Practice PollPoll: My primary work role is:
  6. 6. What is eSource? Digital Equipment (BP Cuff, EKG) IVRS / IWRSePRO Imaging Data EMRs ??
  7. 7. FDA “We’re Here To Help” Electronic Source Documentation“This guidance is intended to promote thecapture of source data in electronic form, whichwill help to:– eliminate unnecessary duplication of data,– reduce transcription errors,– promote real-time entry of electronic source during subject visits,– ensure accurate/complete data through electronic prompts”
  8. 8. FDA Perspective“For the purpose of this guidance, the terms eSource documents and eSource data are used to describe source documents and source data for which the original record and certified copies are initially captured electronically.” (page 6)“The eCRF is a vehicle used to assemble all the data from different electronic- and paper-based systems and makes it possible to capture and organize these diverse data in a manner that satisfies the study protocol and that enables the data to be systematically reviewed and analyzed.” (page 6)
  9. 9. FDA “We’re Here To Help” Risk-Based Monitoring“The guidance specifically encourages greater use ofcentralized monitoring methods where appropriate…The extent to which centralized monitoring practicescan be employed will depend to some extent onaccessibility of electronic records.” (page 1, 8)“Source data verification and other activitiestraditionally performed by on-site monitoring can nowoften be accomplished remotely.” (page 5)
  10. 10. Poll #1Poll: How much was spent on Phase 1-3 Clinical...
  11. 11. Poll #1How much was spent on Phase 1-3 clinical trials last year?$40 BILLION $1,200,000 for EVERY employee involved in clinical trials
  12. 12. Total Clinical Trial Costs 5% 4% 6% 12% 26% 18% 29% Source: Medidata CRO Contractor Fact Sheet; June 2012
  13. 13. Monitoring Spend R&D Spend MonitoringPhase 1 $5.6B $1.2BPhase 2 $8.8B $2.7BPhase 3 $25.4B $7.9BTOTAL $39.8B $11.8B Source: 2012 PhRMA Industry Report UNSUSTAINABLE!
  14. 14. Clinical Trials Today# Days Task Category 0 Record patient data on paper forms SOURCE2 – 10+ Manually input data into database EDC On-site comparison of Source to30 – 60+ MONITOR EDC
  15. 15. Clinical Trials Tomorrow# Days Task Benefit 0 Record patient data on electronic forms No Paper 0 Automatically record to database No Errors 0 Remotely review source docs via web No Travel
  16. 16. Poll #2Poll: Direct entry into CRFs meets site GCP re...
  17. 17. Source ≠ CRFExplicit FDA requirements for Source 21 CFR 312.62(b) Patient Case History Criteria Source CRF Timing Original Secondary Workflow Site/Subject Sponsor GCP/Protocol; Analysis; Data Unstructured Structured Owner Investigator Sponsor Validation Review Verify
  18. 18. Source ≠ CRF: PE - eCRFCDASH Preferred Option A (5.14.1) 18
  19. 19. Source ≠ CRF: PE – Paper Source 19
  20. 20. Source ≠ CRF: PE – eSource 20
  21. 21. CRF ≠ Source: Vitals - eCRF 21
  22. 22. CRF ≠ Source: Vitals – Paper Source
  23. 23. CRF ≠ Source: Vitals – eSource
  24. 24. Poll #3Poll: Reviewing CRFs remotely is sufficient to...
  25. 25. Site Responsibility for SourceInadequate/inaccurate case history is 2ND most common site audit finding“Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation” - cited in 60% of investigator warning letters“What is not documented is not done”ICH E6 separates source DOCUMENTS from source DATA
  26. 26. Impact on Monitoring PlanSource Data Verification: what data does need to be verified for accuracySource Document Review: what documents should be reviewed for context, trends, etc.Remote Monitoring: what types of trial data, how frequently, with what toolsChanging Source data: where will changes be made, by whom, when, where is audit trail
  27. 27. Monitor – Site CommunicationFewer onsite visits, but more frequent and relevant site interactionsData clarified by viewing context of documentQueries - total number and response time are reducedCentralized tools „track‟ monitor activity; what % of documents reviewed, how long?
  28. 28. Practical RealitiesAt what level is data signed? Investigator “signs” CRF, do they need to “sign” eSourceeSource design intent versus database; difference between “Yes”, “No”, “Null” valuesEliminate duplicate edit checks; if checked at source, no need for second checkNot all site employees have email address; how to verify identity, grant access
  29. 29. Drawbacks of Targeted SDVReliance on EDC data - not SourceNo source document reviewNo benefit to site workflowSponsor discretion and riskSounds new; but really oldReliance on process, not technology
  30. 30. Contact Details Ed Seguine CEO – Clinical Ink 30