Update on Trial Registration 11 Years after the ICMJE Policy Was Established.
Update on Trial Registration 11 Years after the ICMJE Policy Was Established.
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DOI：
10.1056/nejmsr1601330
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发表时间：
2017-01-26
期刊：
影响因子：
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通讯作者：
Rajakannan T
中科院分区：
文献类型：
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作者：
Zarin DA;Tse T;Williams RJ;Rajakannan T
在期刊编辑实行试验注册政策之后的十年里，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出版，最终推动循证医学的发展。试验注册是 TRS 的基础组成部分。在本文中，我们评估了试验注册对 CRE 的影响，涉及两个关键目标：(1) 建立所有试验的可公开访问且结构化的公共记录；(2) 确保访问研究期间发生变化的带有日期标记的方案详细信息。在描述了国际试验注册情况后，我们总结了迄今为止已发布的注册法律和政策对 CRE 影响的证据。我们使用 ClinicalTrials.gov 注册数据提出三项分析，以说明评估和监测 TRS 的方法：(1) 注册时间（即试验开始前[预期]或试验开始后[回顾性或“晚期”]；(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特异性和一致性程度；(3) 对已发表文献的调查 描述 ClinicalTrials.gov 数据如何用于 CRE 研究。这些发现表明，虽然 TRS 正在很大程度上朝着目标迈进，但主要利益相关者在未来十年需要做更多的事情。
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.