Laboratory for Informatics Development, National Library of Medicine, NIH Clinical Center, Bethesda, Maryland 20892, USA.
J Am Med Inform Assoc. 2013 Jun;20(e1):e169-74. doi: 10.1136/amiajnl-2012-001501. Epub 2013 Feb 9.
To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)--namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed.
Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010-2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample).
To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011.
Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories. This new integrated knowledge source can facilitate research prioritization, clinical guidelines creation, and precision medicine.
The five selected journals adhere well to the policy of mandatory trial registration and also outperform the registry in adherence to timely registration. ICMJE's URM policy represents a unique international mandate that may be providing a powerful incentive for sponsors and investigators to document clinical trials and trial result publications and thus fulfill important obligations to trial participants and society.
确定国际医学期刊编辑委员会（ICMJE）制定的《统一要求》（URM）中的两项具体标准是否得到遵循，这两项标准分别为：在文稿中包含试验 ID 注册信息，以及及时进行试验注册。
采用计算机分析公开的 Medline 文章数据和临床试验注册数据的观察性研究。我们分析了一组由五个 ICMJE 创始期刊组成的目标期刊，研究了这些期刊在 2010-2011 年期间发表的所有试验文章，以及来自 ClinicalTrials.gov（CTG）临床试验注册中心的数据。我们通过以下方法来衡量对试验 ID 纳入政策的遵循程度：在包含有效试验 ID 的试验期刊文章中所占的百分比（基于期刊的样本）。通过在 60 天宽限期内招募第一个参与者之前对试验进行注册的比例来衡量及时注册的情况。我们还通过 CTG 中所有 II 期及更高阶段干预性试验的年度来检查及时注册率（基于注册中心的样本）。
为了确定试验 ID 的纳入情况，我们分析了五本期刊中的 698 篇临床试验文章。共有 95.8%（661/690）的试验期刊文章包含试验 ID。其中 88.3%的试验-文章链接存储在一个结构化的 Medline 字段中。为了评估及时注册情况，我们分析了从选定的五本期刊中引用的 451 篇文章所涉及的试验。共有 60%（272/451）的文章及时注册，并且随着试验年份的推移，这种趋势也在不断改善（例如，2008 年开始的试验中，有 89%的试验及时注册）。在基于注册中心的样本中，及时注册率从 2006 年注册的试验的 56%到 2011 年注册的试验的 72%不等。
对 URM 注册和试验 ID 纳入要求的遵守提高了 PubMed 的实用性，并以一种重要的方式将其与临床试验存储库联系起来。这个新的集成知识库可以促进研究优先级的确定、临床指南的制定以及精准医学的发展。
这五本选定的期刊很好地遵守了强制性试验注册的政策，并且在及时注册方面的表现优于注册中心。ICMJE 的 URM 政策代表了一种独特的国际授权，可能为赞助商和研究者提供了强有力的激励，促使他们记录临床试验和试验结果的发表，从而履行对试验参与者和社会的重要义务。
