Clinical Trial Simulation in Drug Development

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