What I Submitted to FDA on the Bayesian Guidance
My public comments on Docket No. FDA-2025-D-3217, "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products."
FDA Bayesian Review Checklist
Know the questions a skeptical FDA reviewer will probe — before you're in the room.
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When the Pfizer/BioNTech BNT162b2 trial reported 95% efficacy in November 2020, the world saw a scientific triumph. What most people missed, and what many statisticians still underappreciate, is that the trial's primary analysis was Bayesian. Not frequentist group sequential boundaries. Not O'Brien-Fleming. A posterior probability
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In January 2026, the FDA released updated guidance on the use of Bayesian methods in clinical trials. The document does not read like a manifesto. It reads like an attempt to reconcile competing statistical cultures under real regulatory constraints. On its surface, it is pragmatic and flexible, welcoming Bayesian designs