Know the questions a skeptical FDA reviewer will probe — before you're in the room.
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
A trial reports p = 0.03. As this is less than 0.05, it meets the well-known criterion for being statistically significant. But is the trial outcome also credible? That depends on what you mean by credible—and on information the p-value alone cannot provide. Statistical significance tells you the
