Use of the National Heart, Lung, and Blood Institute Data Repository.
Use of the National Heart, Lung, and Blood Institute Data Repository.
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DOI：
10.1056/nejmsa1603542
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发表时间：
2017-05-11
期刊：
影响因子：
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通讯作者：
Giffen CA
中科院分区：
文献类型：
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作者：
Coady SA;Mensah GA;Wagner EL;Goldfarb ME;Hitchcock DM;Giffen CA
临床试验数据共享研究的重点是阐明试验参与者和研究参与者对数据共享的看法、障碍和态度。然而，一旦临床试验数据被广泛共享，关于文章的利用或相关出版的信息就很少了。我们分析了研究者数据访问请求的管理记录、链接的出版物和文献计量学，以描述国家心肺血液研究所数据库的使用。从2000年1月到2016年5月，共有370名研究者要求从1项或多项临床试验中获得数据。对试验数据的要求一直在增加，195名研究者（53%）在研究期的最后4.4年内提出了要求。要求数据的主要原因是对新问题的事后次要分析（72%），其次是临床试验的分析或统计方法（9%）和荟萃分析或汇总研究（7%）。在提供在线项目说明的172项请求中，只有2项请求是对主要成果调查结果进行重新分析。在100个可用的临床试验中，有88个的数据至少被请求过一次，从数据库可用到第一次请求的中位时间为235天。共有277篇文章基于47项试验的数据发表。来自224篇文章的引文指标表明，一半的出版物的累积引文按主题类别和出版年份标准化后排名前34%。对用于二次分析的试验数据的需求一直在增加。为重新分析或核实原始调查结果的先验目的而要求提供数据的情况很少。
Research on data sharing from clinical trials has focused on elucidating perceptions, barriers, and attitudes among trialists and study participants with respect to sharing data. However, little information exists regarding utilization or associated publication of articles once clinical trial data have been widely shared. We analyzed administrative records of investigator requests for data access, linked publications, and bibliometrics to describe the use of the National Heart, Lung, and Blood Institute data repository. From January 2000 through May 2016, a total of 370 investigators requested data from 1 or more clinical trials. Requests for trial data have been increasing, with 195 investigators (53%) initiating requests during the last 4.4 years of the study period. The predominant reason for requesting data was post hoc secondary analysis of new questions (72%), followed by analytic or statistical approaches to clinical trials (9%) and meta-analyses or pooled study research (7%). Of 172 requests with online project descriptions, only 2 requests were initiated for reanalysis of primary-outcome findings. Data from 88 of 100 available clinical trials were requested at least once, and the median time from repository availability to first request was 235 days. A total of 277 articles were published on the basis of data from 47 trials. Citation metrics from 224 articles indicated that half of the publications have cumulative citations that rank in the top 34% normalized for subject category and year of publication. Demand for trial data for secondary analysis has been increasing. Requesting data for the a priori purpose of reanalysis or verification of original findings was rare.