Adaptive Trial Design

24

Feb

9 min read

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

20

Jan

4 min read

Inside the First FDA-Approved Bayesian Analysis

What REBYOTA teaches us about dynamic borrowing

14

Jan

5 min read

The FDA's Bayesian Guidance: Learning in Theory, Pre-Specification in Practice

The FDA just gave us 25 pages on Bayesian inference in pivotal trials. The philosophical message is clear: Bayesian methods are welcome. Informative priors, borrowing from external data, direct interpretation of posterior probabilities were all explicitly endorsed. The operational message is different: pre-specify everything. Bayesian methods promise learning. Regulators demand

The COVID-19 Vaccine Trial That Put Bayesian Sequential Design on the Map

Inside the First FDA-Approved Bayesian Analysis

The FDA's Bayesian Guidance: Learning in Theory, Pre-Specification in Practice

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