A narrative review on the development of the ethical review mode of multicenter clinical trials in China.
A narrative review on the development of the ethical review mode of multicenter clinical trials in China.
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DOI：
10.21037/atm-22-5213
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发表时间：
2022-11
影响因子：
--
通讯作者：
Luo, Suxia
中科院分区：
文献类型：
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作者：
Ding, Jing;Yin, Yashu;Fang, Keke;Zhang, Wenzhou;Luo, Suxia
我国新药临床试验数量激增，伦理审查在临床试验中发挥着重要作用。但我国的伦理审查存在一定的问题。本综述旨在对多中心临床试验伦理审查模式提出建议，为完善伦理审查机制和提高伦理审查效率做出贡献。通过文献综述、出版物调研、解读我国相关政策和要求等方法，收集可获得的信息，分析多中心临床研究伦理审查模式的现状。根据纳入和排除标准，从国家和国际数据库以及相关治理网站中检索和选择文献和信息。并与美国的相关实践经验进行了比较，借鉴美国的一些成功做法，提出了对我国的建议。中国经历了几个发展阶段。最传统和效率最低的模式是最常用的机构审查委员会（IRB）审查。在IRB审查模式之后，又出现了中心IRB、单一IRB审查等模式，提高了伦理审查的效率。然而，由于我国医院伦理审查制度的发展不平衡，伦理审查责任界定不明确，伦理审查制度的解释存在差距，难以形成共识等多重挑战。多中心伦理审查应采用组长单位伦理审查决定的有条件“批准”模式，逐步建立单一伦理委员会审查，选择最佳伦理委员会。在多中心伦理审查模式下，区域伦理委员会可逐步承担初审责任，最终有助于完善伦理审查机制和效率。
The number of new drug clinical trials in China is surging, and ethics review played an important part in clinical trials. However, there are certain problems of ethical review in China. This review aims to conduct a review to propose recommendations of an ethical review mode for multicenter clinical trials and ultimately contribute to improving the ethics review mechanism and the efficiency. A literature review, publication research and interpretation of the related governmental policies and requirements in China were conducted to collect available information for analysis of the current situation in terms of the various ethical review modes for multicenter clinical research. The literatures and information were searched and selected from national and international database and related governance website by following some inclusion and exclusion criteria. And a comparation with the relevant practical experience in the USA was conducted to support the proposing of recommendations to China by referring to some successful practice in the USA. China has undergone several stages of development. The most traditional and least efficient model is institutional review boards (IRBs) review, which is most commonly used. After IRB review mode, other modes such as central IRB and single IRB review have emerged, which have improved the efficiency of ethical review. However, multiple challenges exist like, no clear definition of regulatory responsibilities and the consensus is not easy to be made due to the gap of interpretation and the unbalanced development on ethic review system from Chinese hospitals. The multicenter ethical review should adopt the conditional ‘approval’ mode of the leading site’s ethical review decisions, gradually establish a single IRB review and select the best ethics committee. Regional ethics committees can gradually take responsibility for the primary review in the multicenter ethics review model and ultimately contribute to improving the mechanism and efficiency of the ethics review.