臨床研究法に基づく臨床研究審査委員会 (CRB) の実態調査

抄録

Background: Clinical research conducted under the Clinical Trials Act, which came into effect in April 2018 in Japan, must be reviewed by a Certified Review Board (CRB) which is accredited by the Ministry of Health, Labor and Welfare (MHLW). There are no reports of substantial investigations of CRBs on a nationwide basis.

Methodology: Questionnaires were sent to 96 CRBs certified by MHLW as on November 22, 2019 to investigate the number of clinical research proposals each CRB reviewed, how technical experts were involved in the review process, the CRBs' own rules of operation, their income and expenditure, and the intention of accreditation renewal.

Results: Responses were received from 73 out of the 96 CRBs (76％). The CRBs had reviewed 382 new clinical research proposals and 848 transitional proposals, 1,230 in total. Since the total number of proposals, 1,230, was approximately 86％ of the 1,422 clinical studies that had got registered in Japan Registry of Clinical Trials (jRCT) as on October 29, 2019 under the Clinical Trials Act, the results of this survey are considered as valid. Regarding renewal of accreditation, 89％ CRBs (63/71) intend to renew their accreditation by MHLW as scheduled, 1％ (1/71) “Will not renew and will discontinue” and 10％ (7/71) are “Undecided.”

Conclusion: This study provides a clear picture of the current status of CRBs in the country. As some of the CRBs will be refraining from renewing their initial accreditation, we were able to provide meaningful information and suggest a direction for future operations.