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Bayesian Clinical Trials

05
Feb
4 min read

The Post-Hoc Problem: Why Bayesian Pre-Specification Matters More Than the Philosophy

The Bayesian vs. frequentist debate usually centers on philosophy. Priors are subjective! No, they formalize existing knowledge! You're smuggling in assumptions! You're ignoring relevant information! It's a fun argument. It's also the wrong one, at least for regulatory decision-making. The real value

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