一项不孕症中医临床试验的伦理审查总结

发布时间：2018-04-19 19:43

本文选题：不孕症 + 中医临床试验　；参考：《中华中医药杂志》2017年10期

【摘要】：文章以一项多中心随机双盲中医临床试验伦理审批工作为背景,介绍医院的机构伦理委员会(IRB)和项目的数据与安全监察委员会(DSMB)的组成和职能;阐述本项目的伦理审批方式;推行动态伦理,在不同时期对项目的不同侧重点进行审查,初期审查侧重试验设计的科学性与合理性,着眼于研究方案等材料内容的制定,中期审查关注研究进度与研究质量,审核研究方案、病例报告表、知情同意书的优化,结题审查侧重项目的安全性和有效性,聚焦试验的活产率及严重不良事件,实现对项目全过程的监控。鉴于多分中心伦理审批工作的低效性和复杂性,建议采取以项目承办单位审批为主,其余分中心施行快速审查的方式,以减少时间成本,提高中医临床试验效率。
[Abstract]:Based on an ethical examination and approval of a multi-center randomized double-blind clinical trial of traditional Chinese medicine, this paper introduces the composition and functions of the institutional ethics committee of the hospital and the data and safety supervision committee of the project, and expounds the ethical examination and approval mode of the project. Promoting dynamic ethics, reviewing the different emphases of the project in different periods, focusing on the science and rationality of the experimental design at the initial stage, making the materials such as the research scheme, and paying attention to the progress and quality of the research in the mid-term review. Audit research program, case report form, optimization of informed consent form, conclusion examination focus on the safety and effectiveness of the project, focusing on the live rate of the trial and serious adverse events, to achieve the monitoring of the whole process of the project. In view of the inefficiency and complexity of the ethical examination and approval of multi-branch centers, it is suggested that the main method should be the project contractor's examination and approval, and the other sub-centers should carry out rapid examination in order to reduce the time cost and improve the efficiency of the clinical trials of traditional Chinese medicine (TCM).
【作者单位】：黑龙江中医药大学;黑龙江中医药大学附属第一医院;大庆龙南医院;湖北省中医院;湖南中医药大学附属第一医院;温州市中医院;安徽中医药大学第一附属医院;
【基金】：2011年国家重大科技专项——国家公益性行业专项(No.201107005) 黑龙江中医药大学研究生创新科研项目(No.2015004) 世界中医药学会联合会合作项目(No.WFCMS-2016-001)~~
【分类号】：R271.14

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