Best Practices in Clinical Trial Simulations for Adaptive Study Designs

Abstract

In the ever-changing medical world, technology can help pave the road to a better understanding of options available for clinical trial development. Simulation has been used extensively in many areas such as aerospace engineering, weather prediction and automotive design. In recent years, simulation has become much more mainstream in clinical trial design . Simulated clinical trials are used to gain a much richer understanding of how a trial will evolve, quantify uncertainties around benefits and risks, and how likely it is to make the correct decisions. Before a patient enrolls into a trial, that trial can be run with many virtual patients to understand if the study design will address the goals and objectives of the study. In this chapter the concept of clinical trial simulation is introduced, as well as the key components of the simulation process with a few examples of how scenario planning can be done to address specific concerns that are typically raised in drug development .