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DIA 2021 Global Annual Meeting

Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects

Session Chair(s)

John Concato, MD, MPH, MS

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

FDA Update

John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States
Michael Blum, MD, MPH

FDA Update

Michael Blum, MD, MPH

  • Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER
  • FDA, United States
Sebastian Schneeweiss, DrSc, MD

Calibrating RWE Against RCT Evidence: Key Findings From the RCT-Duplicate Project

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
Robert Reynolds, DrSc, FISPE

Industry Update

Robert Reynolds, DrSc, FISPE

  • Vice President, Epidemiology & Patient-Centered Outcomes
  • GlaxoSmithKline, United States
David Thompson, PhD

Replication of RCTs with RWD: Potential Concerns

David Thompson, PhD

  • Senior Vice President, Real World Research
  • Syneos Health, United States