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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)
Initial Learnings From the RCT DUPLICATE Project
Jessica Franklin, PhD
Optum, United States
Principal Consultant, Epidemiology and Real-World Evidence
Industry Perspective
Brande Yaist, MHS
Eli Lilly and Company, United States
Senior Director, Global Patient Outcomes & Real World Evidence
Overview of the DUPLICATE Real World Evidence Demonstration Project
David Martin, MD, MPH
Novartis, United States
Vice President, Head, PCO Center of Excellence
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