Real-World Evidence Generation and Evaluation of Therapeutics Proceedings of a Workshop (2017) / Chapter Skim
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Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 53-60
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From page 53... ...
An ad hoc committee will plan and conduct a 1-day public workshop that will examine opportunities and challenges for incorporating real-world evidence into evaluation of medical products.
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From page 54... ...
• Methodologies and best practices for high-quality, real-world evi dence generation and application, including o Innovations in clinical trial design to maximize value of infor mation for the full range of stakeholders; o Considerations of how evidence generation from existing stud ies could potentially inform the design of future clinical trials and amplify understanding of product efficacy; o Discussion of how shared goals of payers and regulators can better align evidence generation processes used for regulatory evaluation and decisions on use by payers; and o Re-evaluation of traditional distinctions between goals and methods of preapproval and postapproval research. • Other novel methodologies and approaches to improve devel opment and evaluation of products using real-world evidence, including o of Web-based or digital technologies to enhance clinical Use trial evidence collection and participation; and o Techniques and case studies for effectively using electronic health record data.
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From page 55... ...
Food and Drug Administration 9:05 a.m. Stakeholder Perspectives John Carroll Professor of Medicine Co-Medical Director, Cardiac and Vascular Center University of Colorado Hospital Joseph Chin Deputy Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Naftali Zvi Frankel Patient and Consumer Advocate Rhonda Robinson Beale Chief Medical Officer Blue Cross of Idaho Rachel Sherman Deputy Commissioner for Medical Products and Tobacco U.S.
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From page 56... ...
11:00 a.m. Background and Session Objectives John Hernandez, Moderator Head of Health Economics, Value and Access Verily Life Sciences Nigam Shah, Moderator Associate Professor of Medicine, Biomedical Information Research Stanford University 11:05 a.m.
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1:15 p.m. Background and Session Objectives Jesse Berlin, Moderator Vice President and Global Head of Epidemiology Johnson & Johnson Cathy Critchlow, Moderator Vice President and Head, Center for Observational Research Amgen Inc.
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From page 58... ...
Registry Case Study #2: Michael Mack Chair, Cardiovascular Service Line Baylor Scott & White Health Case Study #3: Sentinel Initiative Lesley Curtis Professor of Medicine Director for Pragmatic Health Services Research Duke Clinical Research Institute Observational Health Data Sciences and Case Study #4: Informatics (OHDSI) Nigam Shah Associate Professor of Medicine, Biomedical Information Research Stanford University 2:20 p.m.
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From page 59... ...
3:45 p.m. Reflecting on Tactics and Strategies for a Way Forward: Discussion with Workshop Co-Chairs, Session Moderators, Panelists, and Audience Mark McClellan, Moderator Director Margolis Center for Health Policy Duke University Steven Galson, Workshop Co-Chair Senior Vice President for Global Regulatory Affairs and Safety Amgen Inc.
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From page 60... ...
Food and Drug Administration 4:20 p.m. Moderated Discussion with Session IV Panel and Audience 5:00 p.m.
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