Clinical Research Involving Children: Registration, Completeness, and Publication
Clinical Research Involving Children: Registration, Completeness, and Publication
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DOI：
10.1542/peds.2010-2847
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发表时间：
2012-05-01
期刊：
影响因子：
8
通讯作者：
Kane, Robert L.
中科院分区：
文献类型：
--
作者：
Shamliyan, Tatyana;Kane, Robert L.
背景与目的：有效的儿童保健必须建立在对最佳研究证据进行全面分析的基础上。本研究的目的是检查注册，完整性和出版的研究涉及children.METHODS：我们搜索了ClinicalTrials.gov注册表，以确定所有封闭的研究涉及儿童和检查他们的完整性和可用性的结果。我们检查了160个随机选择的美国国立卫生研究院（NIH）资助的研究，从2000年到2010年的同行评审期刊上的出版物和758个随机选择的已完成的study.RESULTS：3428个封闭的研究，涉及在ClinicalTrials.gov确定的儿童，2385（70%）完成，28（0.8%）暂停，152（4.4%）终止，38（1.1%）退出。2001年至2009年，未完成学业（终止和暂停）的比例线性增加了186%，从1.9%增加到8.4%。在152项终止的研究中，48项未报告终止原因，21项引用了安全性问题，83项引用了招募不良或其他管理原因。只有29%的已完成研究被发表。研究完成后平均2年发表。已完成的干预性研究比观察性研究发表的频率更高。完成的行业资助的研究发表的频率低于NIH资助的研究。注册NIH资助的试验发表更经常比unregistered.CONCLUSIONS：结果是不可用的一半以上的研究涉及儿童，揭示了大量的出版偏见。所有涉及儿童的研究都必须在ClinicalTrials.gov上注册和发布结果。儿科2012;129：e1291-e1300
BACKGROUND AND OBJECTIVE: Effective health care for children must be based on thorough analyses of the best research evidence. The objective of this study was to examine registration, completeness, and publication of studies involving children.METHODS: We searched the ClinicalTrials.gov registry to identify all closed studies involving children and examined them for completeness and availability of results. We examined publication in peer-reviewed journals for 160 randomly selected National Institutes of Health (NIH)-funded studies from 2000 through 2010 and for 758 randomly selected completed studies.RESULTS: Of 3428 closed studies involving children identified in ClinicalTrials.gov, 2385 (70%) were completed, 28 (0.8%) suspended, 152 (4.4%) terminated, and 38 (1.1%) withdrawn. The proportion of non-completed studies (terminated and suspended) increased linearly by 186% between 2001 and 2009, from 1.9% to 8.4%. Of the 152 terminated studies, 48 did not report reasons for termination, 21 cited safety concerns, and 83 cited poor recruitment or other administrative reasons. Only 29% of completed studies were published. Publication that did occur was an average of 2 years after study completion. Completed interventional studies were published more often than observational studies. Completed industry-funded studies were published less often than studies funded by the NIH. Registered NIH-funded trials were published more often than unregistered.CONCLUSIONS: Results are unavailable for more than half of the studies involving children, revealing a substantial publication bias. Registration and posting of results on ClinicalTrials.gov should be mandatory for all studies involving children. Pediatrics 2012;129:e1291-e1300