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Regulatory Science

17
Mar
13 min read

Bayes through the Looking-Glass: Assessing the Credibility of Clinical Trial Outcomes by Inverting Bayes’s Theorem

A trial reports p = 0.03. As this is less than 0.05, it meets the well-known criterion for being statistically significant. But is the trial outcome also credible? That depends on what you mean by credible—and on information the p-value alone cannot provide. Statistical significance tells you the

12
Mar
5 min read

What Randomization Can't Fix

The last post argued that how you randomize is a design decision most biostatisticians treat as settled before the interesting work begins. REMAP-CAP showed what happens when that decision is taken seriously. The carat package showed that even standard covariate-adaptive randomization has inferential consequences most of us aren't

26
Feb
4 min read

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."