Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis, Minnesota 55455, USA.
Pediatrics. 2012 May;129(5):e1291-300. doi: 10.1542/peds.2010-2847. Epub 2012 Apr 23.
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.
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.
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identified in ClinicalTrials.gov, 2385 (70%) were completed, 28 (0.8%) suspended, 152 (4.4%) terminated, and 38 (1.1%) withdrawn.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.
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.
有效的儿童医疗保健必须建立在对最佳研究证据的彻底分析之上。本研究的目的是检验涉及儿童的研究的注册、完整性和发表情况。
我们在 ClinicalTrials.gov 注册处搜索了所有涉及儿童的已关闭研究，并对其完整性和结果可用性进行了检查。我们检查了 2000 年至 2010 年期间随机选择的 160 项由美国国立卫生研究院（NIH）资助的研究和 758 项随机选择的已完成研究在同行评议期刊上的发表情况。
在 ClinicalTrials.gov 中确定的 3428 项涉及儿童的已关闭研究中，有 2385 项（70%）完成，28 项（0.8%）中止，152 项（4.4%）终止，38 项（1.1%）撤回。未完成研究（终止和中止）的比例在 2001 年至 2009 年间线性增加了 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 项提到安全问题，83 项提到招募不良或其他行政原因。只有 29%的完成研究发表了。实际发表的时间平均是研究完成后的 2 年。完成的干预性研究比观察性研究发表的更为频繁。由行业资助的完成研究比由 NIH 资助的研究发表的更为罕见。在 ClinicalTrials.gov 上注册的 NIH 资助试验比未注册的试验发表的更为频繁。
超过一半涉及儿童的研究结果无法获得，这揭示了一个严重的发表偏倚。所有涉及儿童的研究都应强制在 ClinicalTrials.gov 上注册和发布结果。
