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
Between late 2024 and late 2025, FDA approved six rare-disease therapies supported primarily by single-arm trials. None of these sponsors ran randomized controlled trials. All received traditional or accelerated approval. What separated success from rejection wasn’t luck or regulatory leniency. It was understanding what evidence compensates for the absence
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
