Exclusion of Pregnant Women From Industry-Sponsored Clinical Trials
Exclusion of Pregnant Women From Industry-Sponsored Clinical Trials
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DOI：
10.1097/aog.0b013e3182a9ca67
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发表时间：
2013-11-01
影响因子：
7.2
通讯作者：
Lyerly, Anne Drapkin
中科院分区：
文献类型：
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作者：
Shields, Kristine E.;Lyerly, Anne Drapkin
目的：由于缺乏可用于妊娠期疾病循证治疗的人类数据，人们呼吁更多地将孕妇纳入研究中，但目前对其代表性的程度了解甚少。我们的目标是衡量当前将孕妇排除在行业资助的临床试验之外的情况，作为未来比较的基线。方法：我们从2011年10月1日至2012年1月31日期间发布在www.ClinicalTrials.gov上的招募有生育能力的女性的研究中收集了数据。该审查仅限于由制药行业资助的公开的美国第四阶段干预研究，评估对孕妇可能会经历但不限于孕妇的病症的治疗，并且不涉及分类为以下类别的药物：潜在致畸性。如果纳入或排除标准中没有提及怀孕，我们会联系研究代表以确认孕妇可以入组。结果：在 558 项符合行业赞助的研究中，有 5 项 (1%) 是专门为孕妇设计的。在 367 项经过验证的纳入和排除标准的 IV 期临床试验中，348 项 (95%) 排除了孕妇，19 项 (5%) 没有排除。结论：我们发现将孕妇排除在行业赞助的临床试验之外是常见做法。超越反射性排除并制定将孕妇纳入临床研究的深思熟虑的标准，可能会推进证据基础，为怀孕期间的治疗决策提供信息，并为妇女和儿童带来更好的健康结果。
OBJECTIVE: The lack of human data available to inform evidence-based treatment for illness during pregnancy has led to calls for greater inclusion of pregnant women in research, but the extent of their current representation is poorly characterized. Our objective was to measure the current exclusion of pregnant women from industry-sponsored clinical trials as a baseline for future comparison.METHODS: We compiled data from studies enrolling women of childbearing potential posted on www.ClinicalTrials.gov between 1 October 2011 and 31 January 2012. The review was limited to open United States-based phase IV interventional studies sponsored by the pharmaceutical industry evaluating treatment of conditions that may be experienced by but are not limited to pregnant women and did not involve a medication classified as potentially teratogenic. If there was no mention of pregnancy in the inclusion or exclusion criteria, we contacted a study representative to confirm that pregnant women could be enrolled.RESULTS: Of 558 qualifying industry-sponsored studies, five (1%) were designed specifically for pregnant women. Of 367 phase IV clinical trials with verified inclusion and exclusion criteria, 348 (95%) excluded pregnant women and 19 (5%) did not.CONCLUSION: We found the exclusion of pregnant women from industry-sponsored clinical trials to be common practice. Moving beyond reflexive exclusion and developing thoughtful criteria for inclusion of pregnant women in clinical research would likely advance the evidence base to inform treatment decisions during pregnancy and lead to better health outcomes for women and children.