Modeling and Simulation in Bayesian Clinical Trial Design
Scott Berry, Berry Consultants  *Gary L Rosner, Johns Hopkins University 

Keywords: Bayesian statistics, Modeling, Oncology

Clinical studies in cancer are becoming more complex, especially in early phase studies. The complexity arises because of many factors, such as the desire to be more efficient than in the past, the need to address endpoints other than tumor shrinkage with newer targeted agents, and the current interest in determining the best drugs for the specific molecular characteristics of each tumor. Many studies that incorporate Bayesian ideas in their design often require modeling and simulation to help determine the best design or to evaluate each study's operating characteristics. In this talk, we will discuss several examples of designs that benefitted from modeling and simulation.