第３章　日本における臨床試験（治験）と医薬品の適正使用の変遷（1980～2010）

抄録

This paper reviews the status of clinical trials and appropriate use of drugs from historical perspectives in the last 30 years in Japan. Industry-sponsored clinical trials in Japan began being regulated under the revised Pharmaceutical Affairs Law in 1980. Japanese modifications were made to the ICH-GCP, which reached step 4 in May 1996, and a notification called the New GCP was issued in March 1997. This was fully implemented as of April 1998. The number of clinical trials, however, dropped sharply after 1998. Patients worldwide who have no drugs for their diseases are waiting for new medicines. Clinical trials must be held as part of a scientific and valid process. Physicians have a duty to use new medicines considering a balance of effectiveness and safety. In Japan, several yakugai cases were observed in the past. They were not only caused by the toxicological effects of drugs but were also due to social factors in drug use. Responding to these scandals, new regulations were developed and contributed to the appropriate use of drugs in Japan. PMID: 25272637 [Indexed for MEDLINE]