论如何提高多中心临床试验的审批效率

摘要

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.%目的 分析多中心临床试验项目审批环节的时间消耗情况,探讨提高审批效率的手段.方法 回顾性分析2012年以来我院批准的多中心临床试验项目246项.我院为组长单位的为A组,参加单位的为B组,根据是否采用快速审查方式将B组分为B1(会议审查)和B2(快速审查)组.分析各组伦理审查时间、签署合同时间、启动试验时间和项目审批总时间,自组长单位批准后至参加单位材料递交的时间.结果 在多中心临床试验审批中,签署合同耗时最多,约占41％.是否组长单位对审批环节的耗时未见明显影响.B1组与B2组项目总时间的平均值分别为180.94天和140.36天(P＜0.05),B1组伦理审查的平均时间较B2组长约20天(P＜0.01).组长单位伦理批准后约96.54天,才向参加单位递交审查材料.结论 对于组长单位已经审批通过的项目,尽快递交参加单位,并且采用快速审查方式可能明显缩短伦理审查时间,从而减少项目审批的总耗时.