Effectiveness evaluation of the multi-center cooperative supervision and management system in multi-center clinical researches in Beijing
Objective:This article aims to analyze the effectiveness of the supervision and management system for clinical research projects in the multi-center cooperation in the medical and health field of the Beijing Science and Technology Plan,and to evaluate the impacts of this system on the clinical research initiating work.Methods:A total of 181 research units were included in 23 multi-center clinical research projects in the medical and health field of Beijing Science and Technology Plan from 2015 to 2019.According to whether or not the multi-center cooperative supervision and management system were applied,they were divided into intervention group and control group,i.e.,89 intervention groups and 92 control groups.The ethical review and enrollment efficiency of research units in the start-up stage were compared.Results:The approval time of the ethical review and the enrollment time of the first subject in the intervention group were shorter than that in the control group:the average time for the approval of the ethical review in the two groups was 150.1 days and 431.5 days,respectively,and the enrollment time of the first subject was 65.2 days and 113.6 days,respectively.The approval rate and enrollment rate of ethical review were higher than those in the experimental group:the approval rate of ethical review was 100.0％and 80.4％,respectively,and the enrollment rate was 100％and 91.9％,respectively,which was statistically significant(P＜0.05).Conclusion:The use of the supervision and management system for clinical research projects in the multi-center cooperation can improve the ethical standardization and increase the enrollment rate.
clinical researchstartup phaseethical approval timefirst case enrollment durationresearch quality
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