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Activity Number: 298 - Confirmatory Adaptive Designs in Action: Recent Advances in Statistical Frameworks and Operational Models
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #310997
Title: An Overview of U.S. Regulatory Considerations for Confirmatory Adaptive Design Trials
Author(s): John Scott*
Companies: FDA
Keywords: adaptive design; clinical trials; regulatory; bayesian
Abstract:

In November, 2019, the U.S. Food and Drug Adminsitration issued a final guidance on Adaptive Design Clinical Trials for Drugs and Biologics. This guidance, which replaced an earlier 2010 draft guidance on the same topic, provides recommendations about the use of adaptive clinical trial designs in FDA-regulated research, especially in late-phase product development. The guidance focuses on four key principles that such trials should satisfy: (1) controlling the chance of erroneous conclusions, (2) producing reliable treatment effect estimates, (3) detailed prespecification, and (4) maintenance of trial conduct and integrity. In this talk, I will review the adaptive design guidance, discussing how it fits into the existing framework of laws and regulations that govern how drugs and biologics are brought to market in the United States. I will also touch on related topics in the area of complex and innovative trial design, including the ongoing development of regulatory recommendations on Bayesian adaptive designs and other Bayesian approaches to clinical trials.


Authors who are presenting talks have a * after their name.

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