摘要
目的分析药物临床试验中伦理审查各环节耗时情况,探讨提高伦理审查效率的措施。方法选取2018年1月1日至2023年11月30日本伦理审查委员会完成初始审查的药物临床试验项目,统计分析各个审查环节所需时间。结果2023年伦理审查平均总耗时4.38周,总耗时中申办方所用时间约占30%,其次是伦理审查耗时,初审快速审查项目中,伦理审查的各个环节时间耗时均比会议审查时间短。结论伦理审查中,申办方与伦理委员会应各司其职,加强沟通,合力提高伦理审查效率。
Objective To analyze the time consuming of ethical review in drug clinical trials and explore the measures to improve the efficiency of ethical review.Methods The drug clinical trials that completed the initial review by the ethical review committee from January 1st,2018 to November 30th,2023 were selected.The time required for each review process was statistically analyzed.Results In 2023,the average total time of ethical review was 4.38 weeks,and the time of the sponsor accounted for about 30%,followed by the time of ethical review.In the initial rapid review project,the time of all aspects of ethical review was shorter than that of conference review.Conclusion In ethical review,sponsors and ethics committees should perform their respective duties,strengthen communication and work together to improve the efficiency of ethical review.
作者
丛翠翠
王方
刘慧鑫
刘开彦
CONG Cui-cui;WANG Fang;LIU Hui-xin;LIU Kai-yan(Peking University People's Hospital)
出处
《医院管理论坛》
2024年第10期74-77,共4页
Hospital Management Forum
基金
2023年北京大学科研管理课题。
关键词
伦理委员会
审查效率
临床试验
Ethics committee
Review efficiency
Clinical trial
