Simulations for Adaptive Designs in the Regulatory Setting
*Telba Irony, FDA/CDRH 

Keywords: SImulations, Adaptive Designs, Bayesian Designs

In this talk we will discuss the relevance of simulations for designing adaptive clinical trials for regulatory review by the Center for Devices and Radiological Health. Simulations are essential for planning Bayesian clinical studies since no closed formulae are available to assess their operating characteristics particularly for Bayesian adaptive designs. However, I will argue that simulations are also very important even when closed formulae are available because they increase trial predictability helping sponsors prepare for different scenarios, for surprises, and for the costs of the studies.