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ICMJE政策制定11年后的试验注册最新情况。

Update on Trial Registration 11 Years after the ICMJE Policy Was Established.

作者信息

Zarin Deborah A, Tse Tony, Williams Rebecca J, Rajakannan Thiyagu

机构信息

From the National Library of Medicine, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.

出版信息

N Engl J Med. 2017 Jan 26;376(4):383-391. doi: 10.1056/NEJMsr1601330.

Abstract

In the decade following the journal editors’ trial registration policy, a global trial reporting system (TRS) has arisen to supplement journal publication by increasing the transparency and accountability of the clinical research enterprise (CRE), which ultimately advances evidence-based medicine. Trial registration a foundation component of the TRS. In this article, we assess impact of the trial registration on the CRE with respect to two key goals: (1) establishing a publicly accessible and structured public record of all trials and (2) ensuring access to date-stamped protocol details that change during a study. After characterizing international trial registry landscape, we summarize the published evidence of the impact of the registration laws and policies on the CRE to date. We present three analyses using ClinicalTrials.gov registration data to illustrate approaches for assessing and monitoring the TRS: (1) timing of registration (i.e., prior to trial initiation [prospective] or after trial initiation [retrospective or “late”]; (2) degree of specificity and consistency of registered primary outcome measures compared to descriptions in study protocols and published articles; and (3) a survey of the published literature to characterize how ClinicalTrials.gov data has been used in research on the CRE. These findings suggest that, while the TRS is largely moving towards goals, key stakeholders need to do more in the next decade.

摘要

在期刊编辑试行试验注册政策后的十年里,一个全球试验报告系统(TRS)应运而生,通过提高临床研究企业(CRE)的透明度和问责制来补充期刊发表,这最终推动了循证医学的发展。试验注册是TRS的一个基础组成部分。在本文中,我们从两个关键目标的角度评估试验注册对CRE的影响:(1)建立一个所有试验均可公开获取且结构化的公共记录;(2)确保能够获取在研究过程中发生变化的带时间戳的方案细节。在描述了国际试验注册格局后,我们总结了迄今为止已发表的关于注册法律和政策对CRE影响的证据。我们使用ClinicalTrials.gov注册数据进行了三项分析,以说明评估和监测TRS的方法:(1)注册时间(即试验启动前[前瞻性]或试验启动后[回顾性或“延迟”]);(2)与研究方案和已发表文章中的描述相比,注册的主要结局指标的具体程度和一致性;(3)对已发表文献的一项调查,以描述ClinicalTrials.gov数据在CRE研究中的使用方式。这些发现表明,虽然TRS在很大程度上朝着目标迈进,但关键利益相关者在未来十年还需要做更多工作。

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