Clinical trial simulation in drug development.

Clinical trial simulation is the application of old technologies, e.g., Monte Carlo simulation, to a new problem, that problem being how to maximize the information content obtained during the drug development process with an intent to have the greatest chance of "success" in a clinical trial. When the information content of the drug is high, then simulation provides a method to synthesize that information into a coherent package that indicates the sponsor has good control over the pharmacology of the drug. From a purely financial point of view, what simulation offers pharmaceutical companies is the possibility of reducing the number of required studies, maximizing the chances for success in a clinical trial, and possibly shortening development time; all outcomes which will reduce drug development costs. The purpose of this paper is to introduce clinical trial simulation to the reader by discussing its potential in drug development, to briefly review the literature, and to make recommendations and caveats regarding its use.