效率与质量的平衡——构建多中心临床试验伦理审查协调体系与平台的设想

发布时间：2018-07-10 17:22

本文选题：临床试验 + 伦理理论　；参考：《中国新药与临床杂志》2017年10期

【摘要】：随着近年来国内医疗机构承担的多中心临床药物试验项目不断增加,开展这些项目必须的伦理审查出现的质量不一致、效率低下的问题愈发显得突出。为解决上述问题,本文对作者所在机构伦理委员会委员、研究者及试验申办方进行调查;对国内及美国开展多中心临床试验伦理审查情况进行调研和文献分析;比较借鉴美国开展多中心临床试验伦理审查的经验,结合本机构多年的实践,提出在国内构建一个能够平衡效率与质量的,包含中心、联盟、协作伦理审查等模式的伦理审查机制及平台的初步设想。该设想对现行的多中心临床试验伦理审查体系从政策、监管部门、机构伦理委员会建设及审查模式等方面提出了改革建议。
[Abstract]:With the increasing number of multi-center clinical drug trials undertaken by domestic medical institutions in recent years, the quality of ethical reviews necessary to carry out these projects is not consistent and the problem of inefficiency is becoming more and more prominent. In order to solve the above problems, this paper makes an investigation on the members, researchers and sponsors of the institutional ethics committee of the author, and makes a survey and literature analysis on the ethical review of multi-center clinical trials carried out in China and the United States. Comparing with the experience of the United States in carrying out multi-center clinical trial ethical review, and combining with the practice of our organization for many years, we propose to build a domestic organization that can balance efficiency and quality, including centers and alliances. The preliminary assumption of the ethical review mechanism and platform of collaborative ethics review and other models. This paper puts forward some suggestions on the reform of the current multi-center clinical trial ethics review system from the aspects of policy, supervision department, construction of institutional ethics committee and examination mode, etc.
【作者单位】：广州中医药大学第一附属医院伦理委员会;
【分类号】：R95

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