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Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects
Session Chair(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
This session will combine an update on FDA’s Real-World Evidence (RWE) Program for drugs and biologic products with a discussion of interim results from ongoing trial replication analyses that advance our understanding of whether and how observational studies can contribute to evidence of the effectiveness of drug products.
Learning Objective : Describe the current status of FDA’s RWE Program; report on results from the RCT-DUPLICATE project emulating randomized trials with analyses of real-world data (RWD); Identify emerging insights from trial replication efforts.
Speaker(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
FDA Update
Michael Blum, MD, MPH
Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA, United States
FDA Update
Sebastian Schneeweiss, DRSC, MD
Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States
Calibrating RWE Against RCT Evidence: Key Findings From the RCT-Duplicate Project
Robert Reynolds, DRSC, MSC, FISPE
Vice President, Global Epidemiology, CMO, R&D, GSK, United States
Industry Update
David Thompson, PHD
Founder and Principal Consultant, Rubidoux Research LLC, United States
Replication of RCTs with RWD: Potential Concerns
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