Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.
Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.
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DOI：
10.1371/journal.pone.0068409
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Cimino JJ
中科院分区：
文献类型：
--
作者：
Huser V;Cimino JJ
为了了解人类临床试验的结果是如何公开的，我们分析了在世界上最大的临床试验注册机构ClinicalTrials.gov注册的大量临床试验。我们考虑了两个试验结果人工制品：(1)存在正式与已登记试验相联系的试验结果期刊文章，或(2)在登记处内存放试验的基本摘要结果。研究样本包括2006-2009年完成的8907项已完成的干预性2期或更高级别的临床试验。大多数试验(72.2%)没有结构化的试验-文章链接。共有2367项试验(26.6%)将基本总结结果交存登记处。其中，969项试验(10.9%)被归类为扩展结果试验，1398项试验(15.7%)被归类为仅要求基本结果的试验。大多数试验(54.8%)根据相关结果文章或基本简要结果(无声试验)没有结果证据，极少数(9.2%)通过登记处书面陈述和公布报告结果。我们的研究分析了围绕临床试验的相关知识体系(我们称之为“试验组”)。我们的结果显示，大多数试验不报告结果，对于那些报告结果的试验，报告类型的重叠很小。我们确定了几种机制，通过这些机制可以增加试验与其公布的结果之间的联系。我们的研究表明，即使将出版物和登记处的结果结合起来，尽管有几个信息渠道可用，试验赞助者也不能充分履行通过链接的结果出版物或基本结果提交向公众通报的任务。
In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world’s largest clinical trial registry. We considered two trial result artifacts: (1) existence of a trial result journal article that is formally linked to a registered trial or (2) the deposition of a trial’s basic summary results within the registry. The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2%) had no structured trial-article link present. A total of 2367 trials (26.6%) deposited basic summary results within the registry. Of those , 969 trials (10.9%) were classified as trials with extended results and 1398 trials (15.7%) were classified as trials with only required basic results. The majority of the trials (54.8%) had no evidence of results, based on either linked result articles or basic summary results (silent trials), while a minimal number (9.2%) report results through both registry deposition and publication. Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the “trialome”). Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.
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影响因子：
15.8
作者：
Ross JS;Mulvey GK;Hines EM;Nissen SE;Krumholz HM
通讯作者：
Krumholz HM
DOI：
10.1056/nejmsa1012065
发表时间：
2011-03-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Zarin DA;Tse T;Williams RJ;Califf RM;Ide NC
通讯作者：
Ide NC
影响因子：
105.7
作者：
Ross, Joseph S.;Tse, Tony;Krumholz, Harlan M.
通讯作者：
Krumholz, Harlan M.
影响因子：
15.8
作者：
Vedula, S. Swaroop;Li, Tianjing;Dickersin, Kay
通讯作者：
Dickersin, Kay
影响因子：
105.7
作者：
Prayle, Andrew P.;Hurley, Matthew N.;Smyth, Alan R.
通讯作者：
Smyth, Alan R.