Risk Mitigation Strategies in Design and Implementation of Adaptive Designs
*Brenda Gaydos, Eli Lilly and Company 

Keywords: Adaptive Designs

The trial implementation strategy is a key consideration in the design of an adaptive trial. It is necessary to first understand operational constraints within a particular development program prior to proposing trial design alternatives for investigation. In addition, as part of the planning process, the likelihood of a successful trial (i.e. a trial that answers the research question) increases if mitigation strategies are put in place a priori for potential implementation issues. In this presentation, completed case studies utilizing sample size re-estimation, response adaptive randomization and seamless 2/3 treatment selection will be used to illustrate approaches taken to build in safeguards. The DMC constructs utilized will also be discussed.