The ClinicalTrials.gov results database--update and key issues.
The ClinicalTrials.gov results database--update and key issues.
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DOI：
10.1056/nejmsa1012065
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发表时间：
2011-03-03
期刊：
影响因子：
--
通讯作者：
Ide NC
中科院分区：
文献类型：
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作者：
Zarin DA;Tse T;Williams RJ;Califf RM;Ide NC
2008年扩大了ClinicalTrials.gov试验登记处，纳入了一个报告摘要结果的数据库。我们总结了结果数据库的结构和内容，提供了相关政策的更新，并展示了如何使用这些数据来洞察临床研究的状态。我们分析了2009年9月至2010年9月期间公开可用的ClinicalTrials.gov数据。截至2010年9月27日，ClinicalTrials.gov每周收到约330个新注册和2000个修订注册，以及30个新结果提交和80个修订结果提交。我们描述了截至2010年9月的79 413个登记处和2178个审判记录的结果。从结果记录的样本队列中，150人中有78人(52%)在发布后2年内发表了相关出版物。在可公开获得的结果记录中，20%报告了两个以上的主要结果衡量标准，5%报告了五个以上。在100个登记记录结果衡量标准的样本中，61%在描述计划分析中使用的衡量标准方面缺乏特异性。在700个结果记录的样本中，每个研究组不同分析人群的平均数量为2.5(中位数，1；范围从1到25)。在这些试验中，24%的参与者报告了90%或更少的结果。ClinicalTrials.gov提供了公众无法获得的研究结果。尽管该数据库允许对正在进行和已完成的临床试验的各个方面进行检查，但其最终的有用性取决于研究界提交准确的、信息丰富的数据。
The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.