Examining the Impact of Real-World Evidence on Medical Product Development Proceedings of a Workshop Series (2019) / Chapter Skim
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Appendix D: Workshop Three Agenda
Appendix D: Workshop Three Agenda
Pages 199-208
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The workshops will advance discussions and common knowledge about complex issues relating to the generation and usage of real-world evidence, including fostering development and implementation of the science and technology of real-world evidence generation and usage. • Workshop One (September 19–20, 2017)
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Welcome and Opening Remarks 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 Session I: Key Considerations for Real-World Evidence Application Session Objectives: • Examine how some organizations are currently considering tradi tional and real-world evidence. • Discuss factors that may be influencing overall cost and time invest ment required by traditional evidence generation.
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• Suggest key considerations in the data collection and evidence generation processes that influence reliability of real-world data. • Discuss how a decision aid laying out key questions and consider ations might help inform current and future studies.
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Food and Drug Administration Luca Foschini Co-Founder and Chief Data Scientist Evidation Health Brande Yaist Senior Director, Global Patient Outcomes and Real-World Evidence Eli Lilly and Company 12:00 p.m. BREAK (Lunch Available Outside the Lecture Room)
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Looking Forward: How a Decision Aid Might Apply to Future Studies Panel Discussion and Audience Q&A Cathy Critchlow Vice President, Center for Observational Research Amgen Inc. Nancy Dreyer Chief Scientific Officer IQVIA Alex John London Clara L
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Session Objectives: • Discuss how variability in treatment delivery and adherence can affect results, including o Potential influence of variation in standard treatment practice, and o Considerations for balancing participant autonomy and safety. • Suggest key factors that could help determine the base comparison and level of control suited to a particular trial.
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ADJOURN WORKSHOP DAY 1 DAY 2: JULY 18, 2018 8:00 a.m. Welcome 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 Session V: How Can Bias in Observational Comparisons Be Assessed and Minimized?
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Looking Forward: How a Decision Aid Might Apply to Future Studies Panel Discussion and Audience Q&A Gregory Daniel, Session Moderator Deputy Director Duke-Margolis Center for Health Policy Jessica Franklin Assistant Professor of Medicine Harvard Medical School Nicole Gormley Team Lead, Division of Hematologic Products Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration Javier Jimenez Vice President and Global Head for Real-World Evidence and Clinical Outcomes Sanofi Heng Li Mathematical Statistician Center for Devices and Radiological Health U.S.
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Panel Discussion with Audience 11:50 a.m. Synthesis of Workshop Discussions 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 12:00 p.m.
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