What Everyone Else Submitted to FDA on the Bayesian Guidance
The disagreements in the comment docket tell you where Bayesian regulatory science still hasn't settled.
FDA Bayesian Review Checklist
Know the questions a skeptical FDA reviewer will probe — before you're in the room.
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The Grammar No One Reads: How Platform Trials Standardize Statistical Design
If you look at a single ComboMATCH substudy on ClinicalTrials.gov, you see a clinical trial. Two-stage design, 30 patients, objective response rate. It looks like any Phase II study. If you look across substudies, you see something different. You see a system. I was a statistician on two SWOG
When the AI Statistician Gets It Right (and Why That's the Dangerous Part)
A few months ago, I asked an LLM to design my clinical trial. It recommended a Bayesian borrowing design for a Phase 2 single-arm oncology trial. The response was fluent, well-organized, and cited the right methods. It was also wrong—in ways that would survive a casual review. That post