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Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project
Session Chair(s)
Jeremy A Rassen, DRSc, MS
Co-Founder and President, Aetion, United States
The Cures Act and the PDUFA IV mandated that the US FDA develop rules to guide industry on the use of real world evidence (RWE) for drug approvals. The session will bring together researchers and regulators to discuss the role of real world evidence.
Learning Objective : Describe the DUPLICATE project replicating RCTs with real world data (RWD) analyses and provide an interim update on the findings from the first year; Discuss key considerations in implementing non-randomized studies using real world data to ensure valid and unbiased findings; Facilitate discussion how real world evidence may be used in regulatory decision-making.
Speaker(s)
Jessica Franklin, PhD
Principal Consultant, Epidemiology and Real-World Evidence , Optum, United States
Initial Learnings From the RCT DUPLICATE Project
Brande Yaist, MHS
Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company, United States
Industry Perspective
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
Overview of the DUPLICATE Real World Evidence Demonstration Project
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