Know the questions a skeptical FDA reviewer will probe — before you're in the room.
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
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
A four-arm neuropathy trial shows what RAR looks like when it's used for the right reasons
