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 Guidance
The COVID-19 Vaccine Trial That Put Bayesian Sequential Design on the Map
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
Calibrated Bayes: The Framework You’re Already Using
If you’ve ever justified a Bayesian design to a regulator, you’ve already been practicing calibrated Bayes, even if you never called it that.