提高多中心临床研究伦理审查效率和质量的探索及思考
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篇名: 提高多中心临床研究伦理审查效率和质量的探索及思考
TITLE:
摘要: 目的:探索提高多中心临床研究伦理审查效率和质量的方法。方法:《关于深化审批制度改革鼓励药品医疗器械创新的意见》《药品注册管理办法(修订稿)》政策出台后,结合我中心实际与实践,分析我中心提高伦理审查效率和质量的方法、完全备案制方式可能存在的问题以及提高多中心临床研究伦理审查效率和质量的途径。结果与结论:我中心采取了多样化的审查方式(会议审查、快速审查、备案制等),通过对研究项目实施分级管理及差异化审查流程,制订备案制操作细则等方式提高审查的效率和质量,跟踪审查和实地访查次数有所增加。我中心伦理委员会在探索过程中,认为完全实行备案制会出现组长单位伦理审查质量难以评估、各中心研究资质及条件不一等问题。为提高多中心临床研究伦理审查的效率和质量,可采用提高中心伦理的审查质量、加强各中心伦理委员会间的沟通与互认、建立伦理委员会秘书初审制等措施,实现效率与质量的平衡。
ABSTRACT: OBJECTIVE: To explore the ways to improve the efficiency and quality of ethical review in multi-center clinical trial. METHODS: After issuing the policy of Opinions on Deepening the Reform of Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices and Measures for the Administration of Drug Registration (Revised Version), combined with the practice of our center, the methods to improve the efficiency and quality of ethical review, the possible problems of complete filling system and the way to improve the efficiency and quality of ethical review in multi-center clinical trial were analyzed in our center. RESULTS & CONCLUSIONS: Our center adopted a variety of review methods (conference review, rapid review, filing system, etc.), implemented hierarchical management and differential review process for research projects, and formulated defined rules of filling system operation and other ways to improve the efficiency and quality of review, doubled the review efficiency, increased the number of follow-up review and field visit. In the process of exploration, the ethics committee of our center believes that the complete implementation of the filing system will lead to problems such as the difficulty to evaluate the quality of the ethical review of the leader unit, different research qualifications and conditions of each center, etc. In order to improve the efficiency and quality of the ethical review of multi-center clinical research, the measures are can be adopted, such as improving the quality of the ethical review of the center, strengthening the communication and mutual recognition of the ethics committees of each center, and establishing the preliminary review system of the secretary of the ethics committee, so as to realize the balance of efficiency and quality.
期刊: 2019年第30卷第23期
作者: 王晶晶,范士志,廖祥丽,段鸿彦,朱剑武
AUTHORS: WANG Jingjing,FAN Shizhi,LIAO Xiangli,DUAN Hongyan,ZHU Jianwu
关键字: 多中心临床研究;伦理备案制;伦理审查质量;伦理审查效率
KEYWORDS: Multi-center clinical trial; Ethical filling system; Ethical review quality; Ethical review efficiency
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