Current Practical Issues in Phase III Clinical Trials

Abstract

Multinational pharmaceutical companies are looking into expanding Phase III clinical trials to regions outside of the United States, Europe, and Japan. Inclusion of Asian sites during drug development could shorten drug development time, perhaps decrease drug development cost, address the issue of ethnic diversity, and accelerate local registrational approvals. Typically, trials are discouraged during the post-new drug application (NDA) submission preapproval stage (Phase III B). With increasing market pressures, however, more and more Phase 111 B studies are being performed for foreign registration or marketing purposes. In order to successfully bid for Phase III participation, a region has to have investigators with proven track records, adequate centralized facilities, responsive regulatory authorities, and ready access. Through participation in multinational studies, a region can increase its visibility in the field of new drug development, facilitate technical transfer, build expertise in clinical trials, and enhance the international standing of opinion leaders. Being fully cognizant of the potential benefits of active involvement in new drug development, Taiwan has been gearing up for an expanded role.