It has been almost 5 years since February 2010 and the release of the FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Utilization of adaptive designs within industry seems to have plateaued. What are some of the barriers? How can these barriers be overcome?

Statisticians who would like to share some of their experiences in implementing these adaptive clinical trials and working with their study teams to adopt these new methodologies will discuss their experiences and the differences between adaptive trial designs and the more traditional trials. Impact on teams and team structures will also be discussed. Newcomers to adaptive trial design are welcome.

This year, the DIA Adaptive Designs Working Group formed the Best Practices Working Group. We will also discuss that project, what we are learning, and answer these questions:

When is it advantageous to utilize adaptive trial designs? What are best practices for implementation of adaptive trial designs?