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When Can You Trust Real-World Evidence for Decision-Making?
Session Chair(s)
Nancy A Dreyer, PhD, 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)
Panelist
Mark B. McClellan, MD, PhD
Duke-Margolis Center For Health Policy, United States
Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy
Panelist
Winona Rei Bolislis, MA
Sanofi, France
Regulatory Science and Policy Manager
Panelist
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Panelist
Brian Bradbury, DrSc, MA
Amgen, United States
Vice President, Center for Observational Research
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