多中心合作监督管理制度在北京市多中心临床研究中的应用效果评价

Effectiveness evaluation of the multi-center cooperative supervision and management system in multi-center clinical researches in Beijing

目的:分析北京市科技计划医疗卫生领域临床研究项目多中心合作监督管理制度的应用效果,探讨该制度对临床研究启动效率的影响。方法:纳入2015—2019年北京市科技计划医疗卫生领域多中心的临床研究项目23项,共181家研究单位,根据是否应用多中心合作监督管理制度分为干预组和对照组,干预组89家、对照组92家,对研究单位启动阶段的伦理审查和入组效率进行对比。结果:干预组研究单位的伦理审查获批时间、首例受试者入组时间均快于对照组:两组伦理审查获批平均时间分别为150.1和431.5 d,首例受试者入组时间分别为65.2和113.6 d;伦理审查获批率和入组率均高于试验组:伦理审查获批率分别为100.0%和80.4%,入组率分别为100%和91.9%,差异有统计学意义(P<0.05)。结论:多中心合作监督管理制度的应用,在启动阶段可以提高临床研究的伦理规范性,促进入组进度。

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.