Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.