DIA/FDA Biostatistics Industry and Regulator Forum

The use of Bayesian methods within medical product development has increased significantly in recent years. While Bayesian methods are more routinely used in design, adaptations within a study, analysis, and decision-making at many points throughout the development process, their use in the confirmatory setting is quite limited. Certainly the use of Bayesian methods in the confirmatory setting is no less scientifically valid than traditional approaches, so questions remain as to what we can do to increase the appropriate use of Bayesian methods to improve the medical development process.
In this session we will provide an overview of challenges and opportunities for the use of Bayesian methods in the confirmatory setting. We will explore specific areas of particular opportunity for their use, and discuss best practices for evaluating the operating characteristics of a design that utilizes a Bayesian approach in the confirmatory setting. This session is related to the recent Complex Innovative Design pilot program session, part of the agency’s broader program to modernize drug development, which includes submission of designs that may utilize Bayesian methods.