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Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making
Session Chair(s)
May F Mo, MBA, MS
Executive Director, Biostatistics
Amgen, United States
This session will provide a global regulatory perspective on the evolving ICH E20 guideline, which aims to establish harmonized principles for adaptive clinical trial designs incorporating Bayesian methods. Regulators from ICH regions will share insights on current guidance if published, review experiences, and anticipated impacts of ICH E20 on innovative drug development. The discussion will focus on alignment opportunities, remaining gaps, and pathways to facilitate consistent application of Bayesian approaches across regions.
Learning Objective : Discuss evolving regulatory perspectives from ICH regions on the use of Bayesian methods in clinical trial design and analysis; Explore challenges and opportunities in achieving harmonized principles under ICH E20 for Bayesian adaptive trials; Understand regional regulatory expectations (FDA, EMA, CDE) and how they influence global drug development strategies; Identify key considerations for implementing Bayesian adaptive design to support regulatory decision-making.
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