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Activity Number: 498 - Making Data and Statistics Impactful Through Inclusivity, Powerful Collaboration, and Effective Innovation
Type: Invited
Date/Time: Thursday, August 11, 2022 : 8:30 AM to 10:20 AM
Sponsor: Stats. Partnerships Among Academe Indust. & Govt. Committee
Abstract #320634
Title: FDA’s Complex Innovative Trial Design Program
Author(s): John Scott*
Companies: FDA / CBER
Keywords: FDA; clinical trials; Bayesian; adaptive trials; drug development

The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to a rapidly evolving drug development landscape. As a result, the FDA and medical product developers are faced with unique challenges and opportunities. The FDA is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design (CID) Pilot Meeting Program. In this talk, I will describe the CID meeting program, review progress to date including case examples, and look ahead to what comes next as we approach the end of the 5-year pilot.

Authors who are presenting talks have a * after their name.

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