[Experience as a model hospital for new good clinical practice (GCP) regulations]

The new good clinical practice (GCP) regulations established by the Ministry of Health and welfare aim to promote clinical trials of new drugs that are ethical, reliable, and scientifically sound. According to these regulations, utmost importance should be placed on considerations of trial participant safety, welfare and the protection of his or her human rights. To this end, the responsibilities of the sponsor, the institution at which the trials are conducted, and the physician in charge have been clarified. These regulations stipulate that a system must be established which makes it possible for a third party to verify the course and conduct of a clinical trial. The new GCP regulations not only set standards for the development of new drugs, they also mark the beginning of a new era in medical science and treatment in Japan.