Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.
Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.
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DOI：
10.7326/m13-0480
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发表时间：
2014-04-01
影响因子：
39.2
通讯作者：
Helfand M
中科院分区：
文献类型：
--
作者：
Hartung DM;Zarin DA;Guise JM;McDonagh M;Paynter R;Helfand M
现在，许多药物和器械试验的结果摘要都需要在ClinicalTrials.gov上报告。评价在ClinicalTrials.gov结果数据库中注册并在文献中发表的试验报告的一致性。ClinicalTrials.gov结果数据库，通过ClinicalTrials.gov和两个电子数据库的手动检索确定的匹配出版物。2009年1月1日之前完成的III期或IV期试验的10%随机样本，其结果在ClinicalTrials.gov结果数据库中，具有两个或多个组。一位评审员从ClinicalTrials.gov结果数据库和匹配的出版物中提取数据。对子样本进行了独立验证。对报告来源之间的基本设计特征和结果进行了比较，并总结了差异。在110项有结果的回顾性试验中，大多数是行业赞助的平行设计药物研究。最常见的不一致是报告的次要结局指标的数量（80%）。有16项试验（15%）报告的主要结局描述不一致，22项（20%）报告的主要结局值不一致。共有38项试验不一致地报告了发生严重不良事件（SAE）的个体数量，其中33项（87%）在ClinicalTrials.gov中报告了更多SAE。在ClinicalTrials.gov中报告SAE的84项试验中，11项出版物未提及SAE，5项报告SAE为零或未发生，21项报告了不同数量的SAE。在ClinicalTrials.gov上报告死亡的29项试验中，28%与匹配的出版物不同。小样本，包括发布到数据库的最早结果，因此可能反映了提交过程的经验不足。报告ClinicalTrials.gov结果数据库和匹配出版物之间的差异是常见的。目前尚不清楚哪个报告来源包含最准确的试验结果。ClinicalTrials.gov可能提供比出版物更全面的试验不良事件描述。
Result summaries are now required to be reported in ClinicalTrials.gov for many trials of drugs and devices. To evaluate the consistency of reporting in trials that are both registered in the ClinicalTrials.gov results database and published in the literature. ClinicalTrials.gov results database, matched publications identified through both ClinicalTrials.gov and a manual search of two electronic databases. 10% random sample of Phase III or IV trials with results in the ClinicalTrials.gov results database, completed before January 1, 2009, with two or more arms. One reviewer extracted data from ClinicalTrials.gov results database and matching publications. A subsample was independently verified. Basic design features and results were compared between reporting sources and discrepancies were summarized. Of 110 reviewed trials with results, most were industry-sponsored, parallel design, drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). There were 16 trials (15%) that reported the primary outcome description inconsistently and 22 (20%) in which the primary outcome value was reported inconsistently. A total of 38 trials inconsistently reported the number of individuals with a serious adverse event (SAE), of which 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported SAEs as zero or not occurring, and 21 reported a different number of SAEs. In 29 trials that reported deaths in ClinicalTrials.gov, 28% differed with the matched publication. Small sample that includes earliest results posted to the database and therefore may reflect inexperience with the submission process. Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. It is unclear which reporting source contains the most accurate account of trial results. ClinicalTrials.gov may provide a more comprehensive description of trial adverse events than the publication.