[Improving the infrastructure for clinical trials in Japan].
It is necessary for us to reform the infrastructure for clinical trials in Japan in this new GCP era. Medical institutions for clinical trials should prepare to implement monitoring and auditing procedures for quality control and quality assurance of clinical trials. It is also necessary to ease the burden and improve the benefits of participating in clinical trials by subjects. Although there has been no effort to educate and train CRC/SC staff at all in Japan, future improvement in this area is needed to bring the quality of Japan's clinical trials up to international standards.
Nakano
S
S
Dept. of Clinical Pharmacology and Therapeutics, Oita Medical University.
D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D017277:Drug Approval; D006801:Humans; D007564:Japan; D008495:Medical Oncology / Q000458:organization & administration; D011785:Quality Assurance, Health Care; D011786:Quality Control