Discussion on How to Improve the Approval Efficiency of Multicenter Clinical Trials / 中国医学伦理学

ABSTRACT

Objective:To analyze the time consumption in the review of multicenter clinical trials and to explore the methods of improving the approval efficiency.Methods:We retrospectively analyzed 246 multicenter clinical trials approved by our hospital from 2012.Group A were trials that our hospital was the leading site while group B were those not.In group B,trials were divided into group B1 (conference review) and B2 (expeditedreview)according to the ethical review methods.Each group's ethical review time,contract signature time,starting experiment time,the total time consumption of review,and the time from the leading site approving to the participating site submitting application were analyzed.Results:In the review of multicenter clinical trials,contract signature cost the most time,accounting for 41％.There was no significant difference in terms of whether to be the leading site.The total time consumption of group B1 and group B2 was 180.94 days and 140.36 days (P ＜0.05),respec tively.The average ethical review time of group B1 was about 20 days longer than group B2 (P ＜ 0.01).There were 96.54 days that the leading site submitted review materials to the participating site after approved.Conclusions:In multicenter clinical trials,for those the leading site has already approved,immediate submission to participating site and choosing the expedited review method may improve the ethical review efficiency,thereby shorten the total approval time consumption.