Limitations of Conducting Clinical Trials in Taiwan
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
F’rinted in the USA. All rights reserved.
LIMITATIONS OF CONDUCTING CLINICAL TRIALS IN TAIWAN YEN-YAUHSIEH,MD FCCP Physician, Department of Medicine, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan, and Professor of Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
Clinical trials demand that investigators pursue absolute truthfulness and objectivity and that they report only honest data. Medical ethics demand that the investigators be in a state of genuine uncertainty regarding the comparative merits of the test and control treatments. Bias, misconduct, and mispresentation in clinical trials are prevalent worldwide. In addition to the universal problems of conducting clinical trials, in Taiwan clinical trials face a number of limitations, including: 1. Lack of qualified, competent clinical investigators, 2. Underpayment of health care providers resulting in poor quality medical service and clinical assessments, 3. Diflculty in recruiting cooperative, compliant patients, 4. Interference with traditional herbal medicines, 5. Criminal penalties for damage incurred during medical care, 6. A no-fault compensation law demanding safety assurance of medical service, 7. Inadequate financial support by local pharmaceutical companies with few assets and intolerance to negative results, 8. A traditional Confucianism doctrine deemed unethical to expose the flaws of the people, and 9. Patronage of traditional herbal medicine out of nationalism. In conclusion, clinical trials in Taiwan are at risk of criminal penalties, are frequently poorly conducted and controlled, and are inadequately scrutinized. As a result, it is extremely difficult to generate high quality clinical trials in Taiwan. Key Words: Clinical trials in Taiwan; Criminal penalties; No-fault compensation; Herbal medicines; Nationalism
THE EFFICACY AND safety of a new drug or a new clinical application for an approved drug can only be reliably documented by a well designed and properly conducted clinical trial. The best approach is a randommized, double-blind, controlled study performed by competent clinical investigators adhering to the guidelines of clinical trials and good clinical practice (GCP). Thus, the availability of high quality clinical trials is
Presented in part at the DIA “First International Taipei Symposium,” August 29-30, 1996, Taipei, Taiwan. Reprint address: Yen-Yau Hsieh, Department of Medicine, National Taiwan University Hospital, 7, Chung-San South Road, Taipei, Taiwan.
essential to the development of the pharmaceutical industry.
MEDICAL ETHICS OF CLINICAL TRIALS Clinical trials belong to a branch of biomedical research which demands that investigators pursue absolute truthfulness and objectivity and that they report only honest data (1). Medical ethics demand that the investigators be in a state of genuine uncertainty regarding the comparative merits of test and control treatments (Equipoise). If a physician knows that one treatment is clear
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