[Influence of new Japanese GCP on pharmaceutical-company-directed clinical trials and physician-directed clinical studies in the surgical field].
The Japanese Ministry of Health and Welfare issued a revised version of Good Clinical Practice (GCP) in 1997 which regulates the method and procedure of new drug development. The largest issue is the discrepancy between the present status of drug development system and requirements by new GCP. Characteristics of phase III study in the surgical field requires a large number of accrued patients, takes long observation time, and much money to achieve. The study needs well-trained doctors, nurses, study coordinators, a data manager, and statisticians. However, conventional study has largely depended on doctors who might not be able to respond to all requirements without the cooperation of other paramedical staff. Pharmaceutical companies could afford in a few months to organize a new drug development system to meet the requirements of the new GCP. However, physician-directed clinical study has insufficient financial support to realize data assurance of high quality. Because the development of actual treatment depends on the results of physician-directed clinical study, a high-level research organization such as in the western countries should be urgently established, and the fruits of the study should be reflected in government policy in the health assurance system.
Nakajima
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Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
D000970:Antineoplastic Agents; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D004345:Drug Industry; D005378:Financial Support; D006801:Humans; D009369:Neoplasms / Q000601:surgery / Q000628:therapy*; D010820:Physicians; D017410:Practice Guidelines as Topic / Q000592:standards*; D012657:Self-Help Groups
D000970:Antineoplastic Agents