Critical Changes in Clinical Trials in Japan
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Drug Information Journal, Vol. 35, pp. 493-495, 2001 Printed in the USA. All nghts reserved.
CRITICAL CHANGES IN CLINICAL TRIALS IN JAPAN SHUICHI ICHIKAWA,MD Director
MASATAKE TAMAKI Planning Division Cardiovascular Hospital of Central Japan, Gunma, Japan
In Japan, until about 10 years ago, clinical trials were conducted in public hospitals undor hospitals ufltliated with medical schools. During that period, written informed consent was not necessary in order to carry out clinical trials. The new Good Clinical Practices created major changes for physicians, including the increase in patients ’ rights and the requirement for written informed consent. Institutional review boards were established at hospitals to ensure that clinical trials are performed ethically. Standard operating procedures based on Good Clinical Practices requirements were created. In order to conduct clinical trials promptly at the Cardiovascular Hospital of Central Japan, clinical research coordinators were introduced. At present, our rate of patient enrollment is fairly high compared to hospitals aflliated with medical schools. Trained clinical research coordinatorys have played a key role in obtaining written informed consent. Ke.y Words: Clinical trial; Good Clinical Practices; Informed consent; Clinical research coordinator; Medical system
BACKGROUND INVESTIGATORS HAVE MANY roles to perform in each clinical trial: checking the protocol, obtaining written informed consent, answering patients’ questions, and so forth. They are simultaneously required to perform their duties as physicians while serving as investigators. Until recently in Japan, clinical trials were conducted in large hospitals affiliated with medical schools or public hospitals, because the Ministry of Health and Welfare ~~~~
This article is based on a presentation made at the DIA 36th Annual Meeting, June 11-15, 2000. San Diego, California. Reprint address: Shuichi Ichikawa, MD, Director, Cardiovascular Hospital of Central Japan, 740 Shimohakoda hokkitu-mura. seta-gun, gnma-pref 377-0061. Japan.
was reluctant to allow clinical trials to be performed in small hospitals or private clinics. Physicians who work in public and medical school-affiliated hospitals tend to have more problems conducting research due to inflexible schedules and restricted functions. As a result, the number of clinical trials conducted in public and medical school-affiliated hospitals has been declining.
THE FACTORS THAT INFLUENCE CLINICAL TRIALS The conduct of clinical trials is influenced primarily by the medical system of the country and patients’ behavior. There are some important features of Japan’s medical system that influence clinical trials. The national health insurance system has achieved almost full coverage of the population. The system
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Shuichi Ichikawa and Masatka Tarnaki
is effective in maintaining patients’ health, however, they have little financial or emotional incentive to participate in
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