How the 2018 FDA Adaptive Design Draft Guidance Can Help to Increase the Use of Adaptive Designs in Industry

• Activity Number: 164 - FDA Adaptive Designs and Master Protocols Guidance for Clinical Trials – Reflection and Outlook
• Type: Topic Contributed
• Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): David Manner*
• Companies: Eli Lilly & Company
• Keywords: Adaptive Designs

Abstract

The FDA released a draft guidance for Adaptive Designs for Clinical Trials of Drugs and Biologics in September 2018 which is intended to replace the 2010 draft guidance. This guidance provides not only a nice overview of different types of adaptive designs and principles for adaptive designs, it also provides practical considerations when designing an adaptive design. For example, the section on Simulations in Adaptive Design Planning includes some useful advice on how to estimate operating characteristics of a trial. Furthermore, this new draft guidance discusses the possible need for interactions with FDA, documentation of simulation results, and reporting a completed trial. Since this draft guidance document provides more guidance for sponsors on how to effectively conduct an adaptive design, more sponsors will likely refer to this guidance when considering different trial designs which should lead to use of more adaptive designs in industry.