How does FDA recommend using Bayesian Statistics to inform Regulatory Decisionmaking around clinical trials?

FDA’s January 2026 draft guidance on Bayesian methodology in drug and biologics trials signals a clear willingness to see Bayesian methods used for regulatory decisionmaking around clinical trials. The guidance lays out how sponsors (i.e., pharmaceutical manufacturers) should pre-specify priors, success criteria, and simulations so that Bayesian designs remain interpretable, control error rates when needed,…

Measuring Hospital Quality

Quality of care is difficult to measure. Even if you had a perfect measure of quality in terms of health outcomes, risk adjustment is imperfect. For instance, academic medical centers are often assumed to have high quality, but actual outcomes observed in the data may not be that good if they also receive the sickest,…