FOI release
Progress on Bayesian methodology guidelines for clinical trials (similar to FDA January 2026 draft)
Some or all of the information requested was not provided because we didn't hold it.
Case reference FOI2026/00323
Received 24 March 2026
Published 11 May 2026
Request
Please provide all recorded information held by the MHRA relating to the development, consideration, or adoption of guidelines similar to the US FDA's January 2026 draft guidance titled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products" (issued by CDER/CBER). This includes, but is not limited to: Any internal plans, reports, correspondence, meeting minutes, or assessments concerning the use of Bayesian statistical methods (e.g., informative priors, posterior probabilities of efficacy, adaptive designs, borrowing of historical/real-world data) in UK clinical trials for drugs and biological products. How such methods are being evaluated in the context of the 2026 updates to the UK Clinical Trials Regulations, MHRA guidance on adaptive designs/in-silico modelling, or the government's "Replacing animals in science" strategy (November 2025), including MHRA's planned involvement in the International Medicines Regulator's Working Group on 3Rs. Any timelines, milestones, or progress updates on developing MHRA-specific guidance or aligning with FDA/EMA approaches. Any correspondence with DSIT, Home Office, EMA, FDA, or other bodies on this topic since 1 January 2026 (or earlier if linked to clinical trial modernisation or alternative methods).
Response
See attached
Documents
This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.
You can browse our other responses or make a new FOI request.