2012 DIA EMRs for clinical research
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EMR functionality for clinical research has long been dreamed about, but how close to reality is it actually? This presentation lays out some basic facts about the viability (or lack thereof) of using EMRs for Phase 1-3 clinical trials.
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2012 DIA EMRs for clinical research
- 1. EMRs for Clinical Research: Hype versus Reality Edward S. Seguine CEO Clinical Ink
- 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. Discussion Points • Industry Metrics • BMS Operational Perspective • FDA Regulatory Viewpoint • Novartis Experience • Recent Industry Activity Audience Participation REQUIRED
- 4. Principle #1 “Everyone is entitled to their own opinions; but they are not entitled to their own facts.” Daniel Patrick Moynihan 4 term US Senator from New York Poll: EDC has DEFINITELY reduced the total cos...
- 5. Principle #2 “All opinions are not equal. Some are a very great deal more robust, sophisticated and well supported in logic and argument than others.” Douglas Adams Author – “Hitchhikers Guide to the Galaxy” Poll: EDC has DEFINITELY reduced the total cos...
- 6. EMRs for Clinical Research?
- 7. Vote via Texting 22333 22333 176644
- 8. Practice Poll Poll: My primary work role is:
- 9. Poll #1 Poll: How much was spent on Phase 1-3 Clinical...
- 10. Poll #1 How much was spent on Phase 1-3 clinical trials last year? $40 BILLION $1,200,000 for EVERY employee involved in clinical trials
- 11. Poll #2 Poll: What is the most expensive activity in a...
- 12. Total Clinical Trial Costs 5% 4% 6% 12% 26% 18% 29% Source: Medidata CRO Contractor Fact Sheet; June 2012
- 13. Monitoring Spend R&D Spend Monitoring Phase 1 $5.6B $1.2B Phase 2 $8.8B $2.7B Phase 3 $25.4B $7.9B TOTAL $39.8B $11.8B Source: 2012 PhRMA Industry Report UNSUSTAINABLE!
- 14. Poll #3 Poll: EMRs will replace EDC for eSource in:
- 15. EMRs for “Research” • Applied Clinical Trials Survey: 71% EHR/EDC will merge within 5 years February 1, 2007 “The possibility of performing a clinical trial with data extracted directly from EHRs was highly impractical and would not likely enter routine use for 15 to 20 years. I now recognize that I significantly underestimated the difficulties.” Paul Bleicher, DIA Global Forum, Dec 2010
- 16. 16
- 17. EMR Certification Certification Commission for Health Information Technology (www.cchit.org) Published EMR functionality standards for clinical research in 2011 80 Certified EMRs
- 18. Poll #3 Poll: What % of EMRs are certified for Clinica...
- 19. EMR Certification Certification Commission for Health Information Technology (www.cchit.org) Published EMR functionality standards for clinical research in 2011 80 Certified EMRs 0 for Clinical Research
- 20. EMR Functionality Electronic Health Records for Clinical Research (www.ehrcr.org) Practical Considerations for Sites using EHRs Certified for Clinical Research 74 Pages User Requirements Functional Profile (IHE, HL7)
- 21. EMR Functionality CDASH Demog, AE, MedHx, ConMed, Physical Exam, Vitals Use of RFD Profile to exchange data with EDC Capture Audit Trail Generate PDFs Password and LogIn Rules Backup and Recovery
- 22. EMR NON-Functionality HITSP RFD Profile (CAP135) 20 of 37 Requirements DO NOT EXIST CCHIT Certification 19 or 35 Requirements DO NOT EXIST HUGE GAPS
- 23. EMR Data Quality Comprehensive Literature Review (35 studies) - Disparity in granularity, format, optional locations, and structure of data - Accuracy and Completeness differ for Acute versus Chronic conditions - Medication lists particularly error-prone due to discontinuations - Lab data the most accurate and complete - Focus on large academic institutions 1“Electronic Health Records and the Reliability and Validity of Quality Measures”, Medical Care Research and Review, February 2010
- 24. EMR Data Availability University of Colorado – Childrens Hospital 1,093 CRF data elements; 47% in the EMR % Available in % of Total Data Type EMR Study Laboratory Tests 100% 18% Demographics 98% 8% Medications 74% 9% Medical History 54% 18% Trial Diagnostics 21% 19% Questionairres 0% 28% 1“Electronic Health Records and the Reliability and Validity of Quality Measures”, Medical Care Research and Review, February 2010
- 25. Myth of EMR as eSource EMRs can’t be “ultimate” eSource goal – Viable when trial data is standard of care – Limited data (demographics, labs, MedHx) – Unaware of protocol specific requirements – Inflexible systems – access, audit trail – Discrepancy between CODING and DISEASE – Twenty years of experience in the UK? – Business value is reduced monitoring not data exchange – 65% of sites are stand-alone practices
- 26. Secondary Use of EMRs • Preliminary site identification based on patient pools • Reporting of Adverse Events • Impact of inclusion/exclusion criteria on trial enrollment BUT, these benefits only accrue IF the EHR data is captured consistently across institutions.
- 27. EMRs for Clinical Research?
Editor's Notes
- Poll: EDC has DEFINITELY reduced the total cos...\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTE1NzYzOTA5MTkIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: EDC has DEFINITELY reduced the total cos...\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTE1NzYzOTA5MTkIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: EMRs for clinical research in how many years?\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTE0NDk2MDkzNDAIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: How much was spent on Phase 1-3 Clinical...\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTcwNjY5MTAIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Press F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTcwNjY5MTAIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: What is the most expensive activity in a...\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTgwOTYwMzI5OQIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: EMRs will replace EDC for eSource in:\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTE5NzU4MTIzNTkIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.
- Poll: What % of EMRs are certified for Clinica...\r\n\r\nPress F5 or enter presentation mode to view the poll\r\nIn an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser:\r\nhttp://www.polleverywhere.com/multiple_choice_polls/LTE1MjkwMTAzOTEIf you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone.