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DIA 2021 Global Annual Meeting
When Can You Trust Real-World Evidence for Decision-Making?
Nancy A. Dreyer, PhD, MPH, FISPE
- Chief Scientific Officer and Senior Vice President
- IQVIA, 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.
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
Winona Rei Bolislis, MA
- Regulatory Science and Policy Manager
- Sanofi, France
Yoshiaki Uyama, PhD, RPh
- Director, Office of Medical Informatics and Epidemiology
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Brian Bradbury, PhD, MA
- Vice President, Center for Observational Research
- Amgen, United States