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When Can You Trust Real-World Evidence for Decision-Making?
Session Chair(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Real-world evidence holds great promise for informing drug development and review. However, enthusiasm about real-world evidence is currently tempered by the absence of firm guidelines about data quality and methods, inhibiting a shared understanding of what constitutes “good enough” real-world evidence and limiting trust in the use of real-world evidence for decision-making. This panel will reflect on lessons learned about real-world evidence from the development, testing, and review of COVID-19 vaccines and treatments.
Learning Objective : Discuss how real-world evidence is being used today by regulators; Describe some of the key aspects of study design and data quality needed to assure reliable real-world evidence.
Speaker(s)
Mark B. McClellan, MD, PHD
Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy, Duke-Margolis Center For Health Policy, United States
Panelist
Winona Rei Bolislis, MA
Regulatory Science and Policy Manager, Sanofi, France
Panelist
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Panelist
Brian Bradbury, DRSC, MA
Vice President, Center for Observational Research, Amgen, United States
Panelist
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