In January 2026, the FDA released updated guidance on the use of Bayesian methods in clinical trials. The document does not read like a manifesto. It reads like an attempt to reconcile competing statistical cultures under real regulatory constraints. On its surface, it is pragmatic and flexible, welcoming Bayesian designs
In September 2016, the FDA approved eteplirsen for Duchenne muscular dystrophy. The advisory committee had voted 7 to 6 against accelerated approval. The FDA's own review team recommended against it. The clinical program consisted of 12 boys, and western blot analysis showed a dystrophin increase of 0.93%
I asked an LLM a question that junior biostatisticians ask senior biostatisticians all the time: Should I use a Bayesian borrowing design for my Phase 2 single-arm oncology trial? Here's what I got back. The LLM Response Should I use a Bayesian borrowing design for my Phase 2
