Big Data Simulation for Better Clinical Trial Design
*Fei Chen, Janssen Research & Development 

Keywords: simulation, cloud computing, clinical trial design

The development and use of computationally intensive, simulation-based methods is at the core of modern clinical trial designs. Simulations are key to evaluate operating characteristics of alternative options and analytical methods, some of the latter such as Bayesian modeling can be computationally intensive in their own right. In this talk, I will present a case study of a large Phase III trial involving multiple endpoints of different measurement types. Through simulation, I will show modeling time-response of the compound can boost power of the final analysis, how different strategies of multiplicity control compare against each other, and how interim analysis can mitigate the risk of trial failure.