Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations

Hosted by the FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA), this event focuses on the Agency’s January 2026 draft guidance, “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products,” which was published to address a PDUFA VII commitment. The guidance outlines key considerations for applying Bayesian methods in clinical trials, including success criteria and operating characteristics, the use of external information in prior distributions, estimands and missing data, software and computational considerations, and the documentation and reporting of Bayesian analyses.

The program begins with a required pre-recorded video that participants may complete at their own pace before the live panel discussion. The recording provides an overview of the guidance and its implications for the design of clinical trials that use Bayesian methodologies.

Intended Audience

Clinical trial professionals, regulatory science professionals, or regulatory affairs professionals involved in clinical trials and studies where Bayesian approaches may be used.

Topics Covered

• A brief introduction to Bayesian approaches
• Success criteria and operating characteristics in Bayesian trials
• Considerations for prior distributions
• Additional topics including missing data and estimands, software usage, documenting and reporting expectations for Bayesian analyses
• Descriptions of specific settings where Bayesian methods have been previously used.

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