FDA released today a new draft guidance on "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products" and is accepting comments until 13Mar2026. The draft guidance frames the Agency's thought's on the use of Bayesian methods in a variety of clinical situations as outlined in the Introduction:
"Bayesian methods can be used in various ways in clinical trials. For example, Bayesian calculations can beused to govern the timing and adaptation rules for an interim analysis in an adaptive design, to inform design elements (e.g., dose selection) for subsequent clinical trials, or to support primary inference in a trial. The primary focus of this guidance is on the use of Bayesian methods to support primary inference in clinical trials intended to support the effectiveness and safety of drugs."
This will obviously be of interest to a wide swath of the scientific community supporting clinical trials and just not the statisticians.
#fda #Statistics #Bayesian
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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