中国循证医学杂志

中国循证医学杂志

规范多中心临床试验势在必行

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随着国家政策对于药品、医疗器械创新的鼓励,我国开展的多中心临床试验和参与的国际多中心临床试验迎来了前所未有的发展契机。在越来越多的临床试验采用多中心设计的同时,我们需要看到目前存在的不足之处。本文从多中心临床试验设计、实施和报告三个阶段归纳汇总多中心临床试验面临的问题与挑战。从降低中心异质性、避免中心效应的角度出发,建议制定多中心临床试验的设计、实施和报告规范,以提高多中心临床试验质量。

With the encouragement of the national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common now than before. However, we need to recognize that there are still some shortcomings in current multi-center trials. In this article, we summarized the problems and challenges and provided corresponding solutions with the aim to reduce heterogeneity between study centers and avoid excessive center effect in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.

关键词: 多中心临床试验; 设计; 实施; 报告; 规范

Key words: Multi-center clinical trial; Design; Implementation; Reporting; Guideline

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1. 中共中央办公厅, 国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. Available at: http://www.gov.cn/gongbao/content/2017/content_5232362.htm.
2. ICH Expert Working Group. ICH harmonized tripartite guideline e9 - statistical principles for clinical trials. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.
3. 国家食品药品监督管理总局. 国际多中心药物临床试验指南(试行). Available at: http://www.sda.gov.cn/WS01/CL0087/114002.html. 2015-01-30/2018-01-01.
4. ICH Press Release. Press release ICH Assembly meeting in Montreal, Canada. Available at: http://www.ich.org/ichnews/newsroom/read/article/press-release-ich-assembly-meeting-in-montreal-canada-mayjune-2017.html.
5. 国家食品药品监督管理总局. 药物临床试验的生物统计学指导原则. Available at: http://www.sda.gov.cn/WS01/CL0087/154780.html.
6. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340(7748): 698-702.