薬理と治療

Abstract

Objectives　Although the Clinical Trials Act（the Act）was enforced in April 2018, the exact number of clinical trials（CTs）registered in the Japan Registry of Clinical Trials（jRCT）is unknown. This study investigates the CTs published in the jRCT and reports the actual condition of the registration status that has not clarified before. Methods　 We identified the specified CTs, etc. submitted by principal investigators for registration in the jRCT between the enforcement date of the Act and March 31, 2019. We extracted the data from jRCT at May 8, 2019 and used them for analysis of this study. We also obtained and used the data of the CTs registered in the University Hospital Medical Information Network between January 2010 and March 2019 to know the actual condition of pre‒enforcement and observation studies. Results　The total number of CTs registered in the jRCT by principal investigators in the studied period was 1,145. Of these, 1,093（95.5％）were specified CTs, 38（3.3％）were non‒specified CTs, and 14 （1.2％）were registration‒directed or other types of CTs. The number of studies registered as non‒specified CTs was small. Among the 1,145 trials, 855（74.7％）were for drugs, 284（24.8％）for medical devices, and 6（0.5％）for regenerative medicine products. Of the target diseases registered in the jRCT in FY2018, 510（44.5％）were the oncology area, 619（54.1％）were the non‒oncology area, and 16（1.4％）were the CTs with healthy subjects. Conclusions　The number of interventional studies decreased in the short term because the regulatory application procedures have become complicated and the application cost has increased due to the enforcement of the Act. Non‒oncology studies account for a larger portion of clinical trial registrations, and their study scales are smaller than those conducted during the transition period from the ethical guidelines.