Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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Appendix C: Workshop Agendas
Appendix C: Workshop Agendas
Pages 107-120
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considered approaches to building resilience, sustainability, and transparency. The discussion included the convergence and integration of clinical research and clinical practice; data sharing and management; and efficient, engaging scientific communication.
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Esther Krofah, Workshop Co-Chair Executive Director FasterCures, Milken Institute SESSION I A MORE PERSON-CENTERED AND INCLUSIVE CLINICAL TRIALS ENTERPRISE Session Objective: • Discuss key priority challenges and opportunities when it comes to person-centeredness and inclusivity in the 2030 clinical trials enterprise 11:10 a.m. A Story in Action: Person-Centeredness and Inclusivity Terris King Former Director, Office of Minority Health Centers for Medicare & Medicaid Services
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The State of Clinical Trials in 2021: A Perspective from Industry Elliott Levy Senior Vice President, R&D Strategy and Operations Amgen Inc.
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• Reduce conduction of "uninformative" clinical trials and prioritize resources to robustly designed trials • Generate a larger amount of high-quality evidence at lower cost • Reduce risk aversion to improve research questions and trial design innovation • Embrace novel statistical techniques to power trials • Connect and embed clinical care and clinical research 1:45 p.m. Breakout Group Report-Outs (10 min)
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WRAP-UP 3:30 p.m. Wrap-Up Discussion and Closing Remarks Steven Galson, Workshop Co-Chair Senior Vice President, Global Regulatory Affairs and Safety Amgen Inc.
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SESSION I THE ROAD TO 2030: AN ATLAS FOR CHANGE 11:10 a.m. Frontline Experience: A Fireside Chat Esther Krofah, Moderator Executive Director FasterCures, Milken Institute Eliseo Pérez-Stable Director National Institute on Minority Health and Health Disparities National Institutes of Health Richardae Araojo Associate Commissioner for Minority Health Director, Office of Minority Health and Health Equity U.S.
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Silas Buchanan Chief Executive Officer Institute for eHealth Equity Marilyn A Metcalf Senior Director, Patient Engagement GlaxoSmithKline 1:40 p.m.
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Esther Krofah, Workshop Co-Chair Executive Director FasterCures, Milken Institute Steven Galson, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc.
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Frontline Experience: A Panel Discussion Physician's perspective on a true "Learning Health Care System" Elizabeth Ofili Contact Principal Investigator Research Centers at Minority Institutions Coordinating Center Patient's perspective on sustainability Bárbara Segarra-Vázquez Dean School of Health Professions, Medical Sciences Campus University of Puerto Rico Industry perspective on building community-based research infrastructure Freda Lewis-Hall Retired Senior Medical Advisor Pfizer Inc.
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Frontline Experience: A Road Already Traveled Dyan Bryson Founder, Patient Engagement Strategist Inspired Health Strategies Pamela Tenaerts Former Executive Director Clinical Trials Transformation Initiative 2:10 p.m. Charge to the Breakout Groups 2:15 p.m.
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Food and Drug Administration Steven Galson, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. Esther Krofah, Workshop Co-Chair Executive Director FasterCures, Milken Institute 3:00 p.m.
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Fox Foundation for Parkinson's Research A perspective on digital law Jan Benedikt Brönneke Director, Law & Economics Health Technologies health innovation hub A perspective on improving software and experience for clinical trial sites Bradford Hirsch Chief Executive Officer SignalPath Research 11:55 a.m. Charge to the Breakout Groups 12:00 p.m.
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"Lightning Round" Breakout Discussion Groups (25 min) The breakout groups will be assigned one of the two following goals and asked to discuss practical applications and partnerships with new technologies that can address key priority challenges, and opportunities aligned with this goal that will move us toward the clinical trials enterprise envisioned for 2030.
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Workshop Wrap-Up Steven Galson, Workshop Co-Chair Senior Vice President, Research & Development Amgen Inc. Esther Krofah, Workshop Co-Chair Executive Director FasterCures, Milken Institute 3:00 p.m.
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