Critical Changes in Clinical Trials in Japan

In Japan, until about 10 years ago, clinical trials were conducted in public hospitals and/or hospitals affiliated 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 affiliated with medical schools. Trained clinical research coordinators have played a key role in obtaining written informed consent.