Advancing the Science of Study Endpoints

Selecting and specifying study endpoints in clinical trials can present challenges to drug developers. Different approval pathways, including traditional approval and expedited pathways, as well as the various types of endpoint approaches that are available can indeed expedite drug development, but can also cause confusion and difficulty in decision-making. The objective of this session is to provide an overview of the approval pathways and endpoint selection considerations. FDA and Industry speakers will share a history, overview of approval pathways, endpoint examples, decision-making considerations, and case studies to help inform future endpoint decisions for drug development programs.