Non-publication of large randomized clinical trials: cross sectional analysis.
Non-publication of large randomized clinical trials: cross sectional analysis.
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DOI：
10.1136/bmj.f6104
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发表时间：
2013-10-29
期刊：
影响因子：
--
通讯作者：
Platts-Mills TF
中科院分区：
文献类型：
--
作者：
Jones CW;Handler L;Crowell KE;Keil LG;Weaver MA;Platts-Mills TF
目的估计在ClinicalTrials.gov注册的大型随机临床试验结果无法向公众提供的频率。设计横断面分析设置至少有500名受试者的试验，这些受试者在2009年1月之前在ClinicalTrials.gov上注册。检索了PubMed、b谷歌Scholar和Embase等数据源，以确定包含试验结果的已发表手稿。最后一次文献检索发生在2012年11月。审查未发表试验的注册条目，以确定这些研究的结果是否可在ClinicalTrials.gov结果数据库中获得。主要结局指标未发表试验结果的频率，以及在未发表的研究中，其结果在ClinicalTrials.gov数据库中不可用的频率。585项注册试验中，171项（29%）未发表。这171项未发表的试验估计总共有299763名研究参与者。对于未发表的试验，从研究完成到最终文献检索的中位时间为60个月。获得行业资助的试验（150/468,32%）比未获得行业资助的试验（21/117,18%）不发表更为常见，P=0.003。在171项未发表的试验中，133项（78%）没有在ClinicalTrials.gov上找到结果。在这组大型临床试验中，未发表结果的情况很常见，ClinicalTrials.gov数据库中结果的可用性有限。大量的研究参与者暴露在参与试验的风险中，而没有伴随着试验结果的传播而带来的社会效益。
Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysis Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database. Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov. Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.
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