Keywords: Bayesian, BSWG, drug development
Bayesian methods provide a framework for leveraging prior information and data from diverse sources to determine probabilities relevant to inferences about issues arising at all stages of medical product development, including realistic quantification of the benefits and risks essential to health economic evaluation. The Bayesian approach provides important information for decision-making and has the potential to play an important role throughout the drug/device development process lifecycle. In 2011, we formed the DIA Bayesian Scientific Working Group (BSWG) to bring together representatives from academia, industry, and regulatory in order to overcome hurdles to implementing Bayesian approaches and to encourage regulatory acceptance of the use of Bayesian methods. In this talk, I will provide an overview of the BSWG. Furthermore, I will provide an industry perspective on the use of Bayesian methods in drug development, highlighting examples that demonstrate the impact of using Bayesian methods to enhance the decision-making process and design of clinical trials.