Standardizing Clinical Study Designs for Accelerating Drug Development

The goal of drug development must be to eliminate from further development those compounds that are not worthy of further investment and to eliminate them as soon as possible. Issues in dealing with early clinical trials in man and questions regarding their necessity are presented. The argument is made that early Phase I and Phase II trials, or at least the reasons for running them, must be standardized rigidly across all drugs in a portfolio and that early Phase II trials must be made definitive in the patient population of interest. An example of such a scheme is given. A list of intangible benefits of a standardized process is also offered.