Simulation of clinical trials

Computer simulation of clinical trials has evolved over the past two decade s from a simple instructive game to "full" simulation models yielding pharm acologically sound, realistic trial outcomes. The need to make drug develop ment more efficient and informative and the awareness that many industries make extensive use of simulation in product development have advanced consi derably the use of simulation of clinical trials in pharmaceutical product development over the past decade. The structural and stochastic components of trial simulation models are explained as a prelude to a Listing of repre sentative simulation projects, reflecting investigative applications of sta tistical methods, trial design comparisons, and full simulation of new drug s being developed. Lessons learned from these projects are reviewed in the context of their current impact and potential for influencing the future of drug development.