[The guideline for clinical trials proposed by Japan Society for Cancer Therapy (JSCT)].
The purpose of the guideline is to improve the quality of clinical trials (especially in phase III) which are performed by the members of Japan Society for Cancer Therapy. It was summarized the following 5 points: 1) clinical studies using new anti cancer drugs after its permission by Ministry of Health of Welfare, 2) not only evaluation of the effect of new drugs, but also evaluation of multidisciply therapy of specific organ cancer, 3) the dose and administration method of the drug, which was admitted by ministry of Health & Welfare may be deviated by researcher, 4) true endpoint the therapy is patients' survival and 5) verification of hypothesis is requested to perform well planned randomized controlled trials. Much more, the problems of its clinical application, eg. qualification and authorization of coordinator, evaluation criteria (each organ specific evaluation criteria made by JSCT must be used in the clinical studies), evaluation of QOL, were referred.
Kurihara
M
M
Dept. of Gastroenterology, Toyosu Hospital, Showa University, Japan.
D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D008495:Medical Oncology; D009369:Neoplasms / Q000628:therapy*; D012955:Societies, Medical
D000970:Antineoplastic Agents