Bayesian Priors in Clinical Trials: Why Historical Borrowing Reduces Sample Size
A simulation study on why historical control borrowing reduces sample size, and what happens when the history is wrong
FDA Bayesian Review Checklist
Know the questions a skeptical FDA reviewer will probe — before you're in the room.
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The Simulations Behind Comment 3
Last week I published what I submitted to the FDA on their January 2026 Bayesian guidance. Comment 3 argued that when you compose Bayesian trial components (priors, borrowing, sequential monitoring), the system's operating characteristics can diverge from what component-level analysis predicts. This post shows you the math. The
Your Randomization Scheme Is a Design Decision, Not a Coin Flip
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