New FDA guidance that’s a ‘huge deal’ for clinical trials

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...
The BMJ

FDA is now “open to bayesian statistics”: transformational change or new Pandora’s box?

The US Food and Drug Administration (FDA) is now “open to bayesian statistics,” contrasting this with the frequentist approach that the agency and the drug industry have historically relied on for ...

How to speed up the search for cures through a change in probability theory

Marty Makary was appointed commissioner of the Food and Drug Administration (FDA) in 2025. The prominent surgeon, medical ...
Nature

Bayesian Statistics and Inference

Bayesian statistics represents a powerful framework for data analysis that centres on Bayes’ theorem, enabling researchers to update existing beliefs with incoming evidence. By combining prior ...
JD Supra

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...