ABSTRACT
The decision processes of designing clinical trials have followed a largely ad hoc manner, driven by empiricism and embracing concepts such as “what was done previously” and “it has always been done this way.” In contrast, other disciplines have been effectively designing experiments using statistical techniques to aid design for many years, but it is only recently that these methods have filtered into the clinical pharmacological arena. Simulation has become a powerful tool for the practitioner due to its generality of application to a wide array of potential problems. In many cases, it can be employed without the practitioner being required to derive closed form solutions to complex statistical problems that would otherwise remain inaccessible. In addition, simulation gains credibility with the nonscientist since it can be explained in essentially nonscientific terms, which allows its transparency to be grasped with ease. It is not surprising, therefore,
that clinical trial simulation (CTS) has been used in designing clinical trials in drug development (1-3).
