ABSTRACT

There is recent and growing interest in using computer simulation of clinical trials to improve clinical trial design. Simulating clinical trials, applying techniques commonly used in other technology-based industries such as the aerospace industry, can allow clinical trial designers to thoroughly test their designs and analyze the simulated results before actually conducting a clinical trial. Herein we describe investigations into the feasibility and utility of model-based clinical trial simulation (CTS) applied to the clinical development of naratriptan with effect measured on a categorical scale.