薬理と治療

Abstract

Background and Purpose Since 2009, we have performed allocation support for randomized controlled trials conducted by on‒campus researchers in the Kitasato Clinical Research Center. Recently, because high‒quality scientific research practices are required, randomized control trials conducted by on‒campus researchers and consequent allocation work requests to our center have increased. Because work requirements differ among studies, including methodologies and implementation environments, issues regarding work quantity and complexity, like personnel shortage, have arisen. To improve efficiency, in 2014, we constructed a random allocation automation system（KiRS）for web‒based allocation registration. We have provided allocation support via KiRS for some clinical studies since March 2014. In this study, we examined the utility of KiRS by investigating subject registration status and surveying users. Methods Based on the allocation registration log, we investigated registration status before and after introduction of KiRS（allocation until November 30, 2014）. Regarding KiRS usage, we surveyed principal researchers of clinical studies（5 cases）that performed allocation support via KiRS. Results Monthly average of registration status before and after introduction of KiRS（5.46±4.77 and 5.88 ±5.48 cases, respectively）did not show a notable change. Average work duration shortened from 6.3±4.0 min/case to 1.5±1.0 min/case before and after introduction of KiRS, respectively. An average response of“good”was obtained from subjects regarding usage simplicity and clarity. Conclusion Because registration status was unchanged after introduction of KiRS, KiRS was not considered to have a major impact. However, because overall work duration of users and of allocation personnel was reduced, KiRS was considered a useful allocation system.