Examining the Impact of Real-World Evidence on Medical Product Development Proceedings of a Workshop Series (2019) / Chapter Skim
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Appendix C: Workshop Two Agenda
Appendix C: Workshop Two Agenda
Pages 191-198
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From page 191... ...
• Workshop One (September 19–20, 2017) focused on how to align incentives to support collection and use of real-world evidence in health product review, payment, and delivery.
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Welcome and Opening Remarks Gregory Simon, Workshop Series Co-Chair Investigator Kaiser Permanente Washington Health Research Institute Session I: When Can We Rely on Real-World Data? Session Discussion Questions: • When can we have confidence in EHR data from real-world prac tice to accurately assess study eligibility, key prognostic factors, and study outcomes?
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Session Discussion Questions: • When conducting research in a real-world setting, are there situ ations that would require special guidance, knowledge, or experi ence in order for clinicians to adequately monitor participant safety and respond appropriately to adverse events? • When does variation between comparison groups (socioeconomic, demographic, etc.)
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Open Discussion with Audience • What conditions make self-monitoring and reporting acceptable? • Does this vary for treatments at different stages of product development or with different baseline knowledge about use in varied patient types and treatment conditions?
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Moderator: Richard Platt, Harvard Medical School Session Discussants Robert Califf Vice Chancellor, Health Data Science, Duke University Scientific Advisor, Verily Life Sciences David Madigan Professor of Statistics Dean, Faculty of Arts and Sciences Columbia University David Martin Associate Director for Real-World Evidence Analytics U.S. Food and Drug Administration
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? o Expectation of large effects o Outcome proximal to treatment o High degree of similarity between comparison groups o Pathway from treatment to outcome is relatively clear, and without lots of complexity or reciprocal effects o Treatment allocation method is relatively transparent 3:40 p.m.
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Welcome and Recap of Day 1 Mark McClellan, Workshop Series Co-Chair Director Duke-Margolis Center for Health Policy Gregory Simon, Workshop Series Co-Chair Investigator Kaiser Permanente Washington Health Research Institute 9:20 a.m. Open Discussion with Audience of Outputs from Day 1 and Potential Components to a "Checklist" for Using Real-World Evidence 10:40 a.m.
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From page 198... ...
• Mechanisms for determining which discrete types of real-world evidence could support regulatory decisions. • Operational challenges and barriers for generating and incorporat ing real-world evidence in the context of a learning health system and how clinicians can best be involved in the collection and usage/ utilization of real-world evidence.
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