It has been almost 3 years since February 2010 and the release of the FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. 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.

What statistical design challenges have you encountered and how have adaptive designs helped?

Have you experienced important team challenges in implementation of adaptive trial design?

What logistical problems have you encountered and how were they managed?