抄録
From America and Europe, there is a great abundance of reports of large-scale randomized clinical trials on various medical problems. They have brought important findings to medical practice. Such knowledge is available in all over the world, including Japan. However, in Japan, we have little experience of randomized multicenter clinical trials, and only a very small number of patients have participated in these studies during the initial period. There are still many diseases and many patients with intractable pathophysiological conditions, and many requests to relieve them or to improve their health, using high-level technology. Why do megatrials fail in Japan? While some have indicated that Japanese physicians have paid scant attention to or have had no experience of large-scaled, multicenter, double-blind, prospective, or randomized clinical trials. I would rather point out the following : we have the health insurance for all Japanese ; the coverage is for anyone, anytime, anywhere in the country, and for any type of conventional treatment ; so most Japanese individuals have little pressure to develop or to resolve medical problems. However, since the consultation time is only about three minutes, the physician does not have enough time to explain details on the clinical trial, therefore the condition of informed consent is poor in Japan. In addition, the peer review system has little tradition and there is no neutral powerful agent as the FDA. Consequently patients are not confident in physicians and the Japanese health care system in general.
