薬理と治療

Abstract

Objectives　The environment around medical research has changed drastically in the past ten years in Japan. To conduct good quality research, it is desirable to have high‒quality research protocols. However, factors associated with the quality of research protocol are unknown. The purpose of this study was to search for factors related to the quality of research protocols. Methods　We included 446 studies for which new applications were accepted by the Nagasaki University Hospital Clinical Research Ethics Committee between August 2015 and November 2017. Research information, researcher information and stress check results are summarized; and regression coefficients, and 95％ confidence intervals, for factors associated with the number of initial comments in a protocol were estimated using generalized estimating equations. Results　The number of comments was significantly higher in the study with intervention compared to the study without intervention（4.3［95％ CI: 0.2 to 8.3］）. Similar trends were observed for the multi‒center trial compared to single‒center（3.4［95％ CI: 1.2 to 5.6］）. There was no significant difference in stress factors. Conclusions　The difficulty of the research itself was found to be associated with the quality of research protocols. It is desirable to provide active support for research with a high degree of difficulty.