影响伦理审查速度的因素分析

Analysis of Factors Affecting the Speed of Ethic Review

目的 通过分析药物临床试验项目伦理审查各环节的耗时情况,探讨提高审查效率的可能途径。方法以在我院药物临床试验伦理委员会审查并拿到批件的99个药物临床试验项目为研究对象,针对会议审查和快速审查项目,分别采集审查各个环节所需时间进行分析。结果 会议审查及快速审查项目的平均审查时间分别为43.7和40天,在一个月内完成审查的项目占40%,绝大多数项目在2个月内完成伦理审查;在伦理审查的各个环节中,从上会到拿到批件耗时最长,约占审查总时长的53.6%。预审环节平均消耗时间为2.1～2.3天;伦理审查过程中,申办方及研究者所用的时间明显多于伦理委员会消耗的时间,在会议审查及快速审查中,申办方及研究者与伦理委员会的耗时比分别为1.69及3.8。结论 在伦理审查的过程中,申办方、研究者及伦理委员会须各尽其责、加强沟通,以提高伦理审查效率。

Objective：To explore the possible methods to improve the efficiency of ethical review by analysis of the time consumptions about the drug clinical trials program in different sections of ethical review. Methods ： Time consumption data in the review procession were collected from 99 trials that were approved by the Clinical Trial Ethical Review Committee of Peking Union Medical College Hospital （PUMCH）. The review included both convened meeting and expedited review. Results： The average time of review for convened meeting and expedited review were 43.7 and 40 days, respectively. 40% of the reviews completed in 1 month, most reviews were done in 2 months. Among all the sections of review, the longest part which took 53.6% of the whole review time was from convened meeting until getting the approval. The average review time for the pre - reviews was 2.1 to 2.3 days. During the ethical review, sponsors and investigators consumed much longer time than ethics committee. For convened meeting and expedited review, the time consumed by sponsors was 1.69 and 3.8 times to the time consumed by ethic committee, respectively. Gonclusion： During the ethical review, each one of sponsor, investigator and ethical committee should take its responsibility to enhance the communication and improve the efficiency of ethical review.