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Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
Session Chair(s)
Amy Xia, PhD
Vice President, Center for Design and Analysis
Amgen Inc., United States
In this session, we will provide a brief overview of the evolving ICH E20 effort with the goal to provide a transparent and harmonized set of principles for the design, conduct, analysis, and interpretation of adaptive clinical trials.
Learning Objective : Considerations specific to adaptive design using Bayesian methods will be discussed. Opportunities and challenges of using Bayesian methods in the regulatory setting will also be highlighted.
Speaker(s)
FDA Bayesian updates
Representative Invited
FDA, United States
E20 Updates
Amy Xia, PhD
Amgen Inc., United States
Vice President, Center for Design and Analysis
Bayesian Trial Design Case Studies
John Zhong, PhD
REGENXBIO, Inc., United States
Vice President, Head of Biometrics
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