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Calibrated Bayes

05
Mar
5 min read

The Simulations Behind Comment 3

Last week I published what I submitted to the FDA on their January 2026 Bayesian guidance. Comment 3 argued that when you compose Bayesian trial components (priors, borrowing, sequential monitoring), the system's operating characteristics can diverge from what component-level analysis predicts. This post shows you the math. The

27
Jan
7 min read

Qalsody: The Probability of Harm

What FDA Actually Decided When the Trial Failed

22
Jan
3 min read

Calibrated Bayes: The Framework You’re Already Using

If you’ve ever justified a Bayesian design to a regulator, you’ve already been practicing calibrated Bayes, even if you never called it that.