Trial Simulation for Adaptive Designs
*Scott Berry, Berry Consultants 

Keywords: Clinical Trial Simulation, Adaptive Designs

In this talk I will describe how Clinical Trial Simulation is used to refine, iterate, and create efficient, adaptive clinical trial designs. The building of clinical trial simulation software is a critical aspect of this process of creating better trial designs. I will discuss the building of software, procedures for sharing and presenting trial simulation.

The use of simulation in the regulatory approval is a critical aspect to creating more innovative trial designs. I describe several topics on regulatory decision making using simulations -- from a regulatory outsider. These topics touch on independent verification of simulations, explorations from regulatory on simulating trials, and accepting simulation results.