FDA draft guidance on Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

21st January 2026

FDA draft guidance on Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

Summary: The FDA’s Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products draft guidance (January 2026) provides non-binding recommendations on how Bayesian statistical approaches can be used in clinical trials submitted in INDs, NDAs, BLAs and supplemental applications. It focuses on the appropriate application of Bayesian methods to support primary inference on a therapy’s safety and effectiveness, particularly in pivotal trials. The guidance highlights ways Bayesian techniques can be applied, including: interim analyses in adaptive designs; dose selection and design elements; the incorporation of external or prior data (e.g., information from previous studies) into analyses; and enhanced decision-making with smaller sample sizes or rare diseases. It also discusses considerations around choice of prior distributions, evaluation of trial operating characteristics, and appropriate reporting and documentation when using Bayesian methods. This reflects FDA’s broader effort to modernise statistical methods in clinical development and support more flexible, efficient trial designs while ensuring rigorous regulatory evaluation.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products

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