Know the questions a skeptical FDA reviewer will probe — before you're in the room.
The Bayesian trial design conversation tends to start after patients are assigned to arms. Priors, borrowing, monitoring, posterior inference. All of it assumes the randomization is settled. Stratified permuted block, 1:1 allocation, done. But how you randomize affects power, balance, ethical allocation, and regulatory credibility. Most biostatisticians treat it
My public comments on Docket No. FDA-2025-D-3217, "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products."
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
