ABSTRACT
Clinical trial simulation is a process that uses computers to mimic the conduct of a clinical trial by creating virtual patients and extrapolate (or predict) clinical outcomes for each virtual patient based on the pre-specified models (Li and Lai, 2003). The primary objective of clinical trial simulation is multi-fold. First, it is to monitor the conduct of the trial, project outcomes, anticipate problems and recommend remedies before it is too late. Second, it is to extrapolate (or predict) the clinical outcomes beyond the scope of previous studies from which the existing models were derived using the model techniques. Third, it is to study the validity and robustness of the trial under various assumptions of study designs. Clinical trial simulation is often conducted to verify (or confirm) the models depicting the relationships between the inputs such as dose, dosing time, patient characteristics, and disease severity and the clinical outcomes such as changes in the signs and symptoms or adverse events within the study domain. In practice, clinical trial simulation is often considered to predict potential clinical outcomes under different assumptions and various design scenarios at the planning stage of a clinical trial for a better planning of the actual trial.
