ABSTRACT
Clinical trial simulation (CTS) is deŒned as a process that uses computers to mimic the conduct of a clinical trial by creating virtual patients and extrapolating clinical outcomes for each virtual patient based on prespeciŒed assumptions/models. CTS is a powerful tool for designing, monitoring, analyzing, and planning clinical trials. It has been used for several decades (Maxwell and Domenet, 1971; Kimko and Duffull, 2003; Chang, 2011). CTS plays an important role in pharmaceutical/clinical research and development. However, it did not receive much attention and become increasingly popular in the pharmaceutical industry until recently (Parmigiani, 2002; Chang, 2011).
