Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.
Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.
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DOI：
10.1002/jcph.212
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发表时间：
2014-04
影响因子：
2.9
通讯作者：
Spigarelli, Michael G.
中科院分区：
文献类型：
--
作者：
Stockmann, Chris;Sherwin, Catherine M. T.;Koren, Gideon;Campbell, Sarah C.;Constance, Jonathan E.;Linakis, Matthew;Balch, Alfred;Varner, Michael W.;Spigarelli, Michael G.
怀孕期间的生理变化会改变许多药物的药代动力学、安全性和功效。对于临床医生来说，由于缺乏已发表的数据，这些药物的安全性常常存在不确定性。本研究旨在综合评价2007-2012年在ClinicalTrials.gov上注册的产科研究的特征和发表模式。对主要结果指标、资金来源、纳入标准和研究结果报告进行了评估。对 Medline/PubMed 进行了手动审查，以确定与 ClinicalTrials.gov 中注册的研究相关的出版物。在总共 93,709 项研究中，有 5,203 项 (6%) 产科研究在 ClinicalTrials.gov 上注册。干预性研究占70%，观察性研究占30%。药物（49%）、手术（13%）和行为干预（12%）的临床试验是最常见的。在介入药物试验中，84% 的试验随机分配到研究组，93% 的试验将安全性和/或疗效的测量作为主要终点。在两年多前完成的 946 项研究 (18%) 中，只有 11% 报告了结果，发表的研究还不到 7%。在一个非常需要安全有效治疗证据的领域，包含高质量试验设计要素的已完成研究的发表率较低，这一点令人担忧。应仔细调查这一趋势的根源。
Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007-2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than two years ago, only 11% had reported results and less than 7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated.
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