Current Practical Issues in Phase III Clinical Trials
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0092-8615/97 Copyright Q 1997 Drug Information Association Inc.
R i n d in Ihe USA. All rights reserved.
CURRENT PRACTICAL ISSUES IN PHASE I11 CLINICAL TRIALS JACQUELINE
DE
SILVA,MD
Senior Regional Medical Director, Bristol-Myers Squibb, Taipei, Taiwan, R.O.C.
Multinational pharmaceutical companies are looking into expanding Phase I l l 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 thefield 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. Key Words: Phase 111 clinical trials; Taiwan;New drug development
AS THE PHARMACEUTICAL industry enters an increasingly competitive era, multinational pharmaceutical companies are rapidly expanding their research and development activities, especially large-scale clinical trials, outside of the United States, Europe, and Japan. Much emphasis has been placed on Asia as a viable region for the conduct of these trials. By involving densely populated regions like Asia, it may be reasonable to expect: 1. A shortened drug development time resulting from the enhanced ability to recruit patients, Presented at the DIA “First International Taipei Symposium,” August 29-30, 1996. Taipei, Taiwan. Reprint address: Jacqueline de Silva, MD, Senior Regional Medical Director, Bristol-Myers Squibb, 4F, 125, 5th Section, Nan-King E. Road, Taipei, Taiwan, R.O.C.
2. A reduced drug development cost, reflecting the lower cost of medical care, 3. Generation of Asian data to address ethnic diversity and the need for bridging trials, 4. Accelerated local product approvals within Asia, and 5. Early local opinion leader development. In Taiwan, before a new chemical entity can be registered, certificates of free sales (CFS) from three of the top 10 countries recognized by the government are required. As a result, local clinical trials are initiated several years after United StatesEuropean approvals, and are in fact Phase IV trials. Interest in participating in preapproval trials, however, is high among Taiwanese physicians. Typically, trials are discouraged during the post-
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