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ICMJE政策制定11年后对临床试验注册的更新
Update on Trial Registration 11 Years after the ICMJE Policy Was Established


Deborah A. Zarin ... 其他 • 2017.01.26

ICMJE临床试验注册政策的最新更新


曹烨†,王济平‡§*

† 中山大学附属肿瘤医院,临床研究部/药物临床试验机构;‡ Division of Surgical Oncology at Brigham and Women’s Hospital, Harvard Medical School;§ NEJM医学前沿

* 通讯作者

 

按照国际医学期刊编辑委员会(ICMJE,International Committee of Medical Journal Editors)的要求,所有的医学期刊都应该把临床研究在纳入第一例参与者时或之前进行注册作为考虑发表的先决条件。各国主管单位也先后制订了相应的法律法规。例如美国食品药品管理修订法案规定临床研究应该在纳入第一例参与者21日之内注册。注册的主要目的是:①提高研究的知晓度,促进患者入组。②尽早把研究发现纳入医疗数据库,避免重复研究和选择性发表研究结果。③有助于临床研究的监管1

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建立全球临床试验报告系统的法律和政策大大增强了临床研究企业的透明度和责任。试验报告系统的三大组成部分分别是试验注册、累积结果报告和个体参与者数据的共享1。因为试验注册要求提供所有相关临床试验的信息(将结果置于更大的背景下)以及预设的研究方案详情(确保遵循科学计划),所以它是对试验结果进行理解和解读的基础。

在本文中,我们描述了现行的试验注册范围,总结迄今注册对于临床研究企业所产生影响的证据。随后,我们提供了使用ClinicalTrials.gov数据进行分析的结果,以提供更多证据说明当前的实践在多大程度上达到了最初为试验注册预想的某些关键目标。最后,我们也提出了下一个十年面临的挑战以及可能的应对方法。





作者信息

Deborah A. Zarin, M.D., Tony Tse, Ph.D., Rebecca J. Williams, Pharm.D., M.P.H., and Thiyagu Rajakannan, Ph.D.
From the National Library of Medicine, National Institutes of Health, Department of Health and Human Services, Bethesda, MD. Address reprint requests to Dr. Zarin at the National Library of Medicine, Bldg. 38A, National Institutes of Health, 8600 Rockville Pike, Bethesda, MD 20894, or at dzarin@mail.nih.gov.

 

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