Reflections on FDA Draft Guidance on Bayesian Methods in Trials—Protecting Scientific Integrity and Evidentiary Standards

This Perspective discusses the use of bayesian methods in clinical trials and the importance of having US Food and Drug Administration (FDA) guidance that provides substantive insights about the methods’ proper role.

Corresponding Author: Scott R. Evans, PhD, MS, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, 6710A Rockledge Dr, Ste 250, Bethesda, MD 20817 (sevans@bsc.gwu.edu).

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