FDA shared a post on LinkedIn:
“Today, we published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.
The guidance provides recommendations on the appropriate use of Bayesian methods, with a primary focus on the use of these methods to support primary inference.
For more information and to submit a comment about this draft guidance.”
Marty Makary, 27th Commissioner of the U.S. FDA, shared a post on X:
“FDA is now open to Bayesian statistical approaches. A leap forward!
Bayesian statistics can help:
- Clinical trial design
- Finding the optimal dose
- Extrapolation to children
- Leveraging phase 2 results in phase 3″
Proceed to the video attached to the post.
More posts featuring Marty Makary.