Nurturing the Clinical Research Leaders of Tomorrow
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Nurturing the Clinical Research Leaders of Tomorrow
Fang-Pin Chrang, MD Tri-Service General Hospital. National Defense Medical Center, Taipei, Taiwan Wing-Kai Chon, MD Departments of Medical Research. National Taiwan University Hospital. Taipei. Taiwan: National Center of Excellence for Clinical Trials and Research Center, Taiwan Min-Hui Chon, MD, MS Division of Clinical Sciences, Center for Drug Evaluation, Taipei, Taiwan Yen-Hrei Chang, MD, MS Center for Drug Evaluation. Taipei, Taiwan Chih-Shrng Wong, MD Tri-Service General Hospital. National Defense Medical Center Taipei, Taiwan Herng-Der Chern, MD, PhD Executive Director Center for Drug Evaluation, Taipei, Taiwan
Kay Words Clinical trial leader: Clinical researcher; Clinical trial; Clinical research: Academic medicine; Taiwan Correspondence Address Hemg-Der Chern, MD. PhD, Center for Drug Evaluation. IF, No. 15-1, Sec.1, Hangiou S . Road, Taipei 100, Taiwan (email: hdchern @cde.org. tw).
Well-designed and performed pivotal trials are critical in providing the efficacyand safety of a new drug for regulatory approval. The success of clinicaldrug development relies on the ability of clinical trial leaders to design and conduct international clinicalstudies. Physicians can do good clinical practice quality trials by fdlowing the protocds accurately but may not be able to design a complicated trial or lead an international clinical trial team. Clinical trial leaders are rarely born but have to be trained and learn through clinical research experience. Academic centers and drug industries have identified this need and proactively designed programs to nurture the clinical trial leaders of tomorrow via multidisciplinaryprograms. Using Taiwan as an example, the government has set up a Center of Excellence for Clinical Trials and Research (CECTR) in four medical centers. These national CECTRs complete a nationwide clinical trial network; strengthen clinical tn'al and clinical research infrastructure; set up national clinical trial and translational research centers; provide education and training for clinical researchers, doctors, nurses, and pharmacists; and improve quality, capacity, capability, and results of clinical trials. They are among the best in the world. Major pharmaceutical companies
INTRODUCTION Clinical research, defined as any investigation involving human subjects, intends to discover or verify the clinical, pharmacological, and other pharmacodynamic effects of investigational new products; to identify any adverse reactions to investigational products; and to study absorption, distribution, metabolism, and excretion of investigational products with the objectives of ascertaining the safety and efficacy of the product. Clinical research consists of a wide spectrum of research activities such as clinical trials, translational research, epidemiological research, health service research, and outcomes research.
sponsored 200 international clinical trials for New Drug Applicationsin Taiwan in 2 W . Our clinical investigators showed their clinical tr
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