Use of Bayesian methodology in clinical trials of drug and biological products [pdf]

It's an FDA guidance doc so you can expect to see this affecting new filings or supplemental filings for upcoming FDA submissions and clinical trial designs. This is good news, statistical plans are always a point of contention during trial design and the submission process. This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.

Accepting Bayesian methods for RCTs is great news and leading biostatisticians like Frank Harrell have been pushing for this change for many years. What I'm most interested to see: will this actually be implemented in practice, or will it be incredibly rare and niche, like Bayesian methods are currently in most biomedical fields?

Anything noteworthy here? I noticed they did not mention causal inference.

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