Menu Back toWhen Can You Trust Real-World Evidence for Decision-Making?

DIA 2021 Global Annual Meeting


When Can You Trust Real-World Evidence for Decision-Making?

Session Chair(s)

Nancy A. Dreyer, PhD, MPH, FISPE

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.

Speaker(s)

Mark B. McClellan, MD, PhD

Panelist

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

Panelist

Winona Rei Bolislis, MA

  • Regulatory Science and Policy Manager
  • Sanofi, France
Yoshiaki  Uyama, PhD, RPh

Panelist

Yoshiaki Uyama, PhD, RPh

  • Director, Office of Medical Informatics and Epidemiology
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Brian  Bradbury, PhD, MA

Panelist

Brian Bradbury, PhD, MA

  • Vice President, Center for Observational Research
  • Amgen, United States