title: [Need to establish academic research organization for cancer clinical trial and clinical research system having clinical investigators and study coordinators, with special reference to promotion of medical and life science research policy].
abstract: There are two types of cancer clinical trials in Japan. One is the therapeutic trial sponsored by a pharmaceutical company for approval of clinical use of new anticancer agent, and another is the clinical trial sponsored by an investigator for establishment of standard state-of-the-art therapy. Advances in cancer chemotherapy can not be achieved without active use of both types of cancer clinical trial. However, the infrastructure, such as academic research organization for cancer clinical trials and clinical research systems having clinical investigators and study coordinators, has not been sufficiently established. New GCP and the Drugs, Cosmetics and Medical Instruments Act are applied only to the therapeutic trials sponsored by pharmaceutical companies, but not to clinical trials sponsored by investigators. There is no National Research Act to cover both types of clinical trial. In this paper, the problems mentioned above are summarized, and a proposal to solve these problems is presented. The Medical and Life Science Research Policy of the Japanese Government should be improved to promote both basic and clinical research. The promotion of clinical research is essential for improvement in the quality of medical practice, appropriate changes in the medical security system, and activation of pharmaceutical science.
authors.affiliation: Nagoya National Hospital.
authors.forename: M
authors.initials: M
authors.lastname: Shimoyama
mesh_terms: D001690:Biological Science Disciplines; D002986:Clinical Trials as Topic; D006801:Humans; D007564:Japan; D008495:Medical Oncology / Q000458:organization & administration*; D016134:Organizational Policy; D012106:Research / Q000458:organization & administration*