如今有多少未成年人参与临床研究？一项估算及重要经验教训。
How many minors are participating in clinical research today? An estimate and important lessons learned.
作者信息
Ittenbach Richard F, Corsmo Jeremy J, Kissling Alison D, Strauss Arnold W
机构信息
Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
University of Cincinnati College of Medicine, Cincinnati, OH, USA.
出版信息
J Clin Transl Sci. 2021 Sep 6;5(1):e179. doi: 10.1017/cts.2021.844. eCollection 2021.
Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were "more than minimal risk." Minors accounted for 0.7-2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.
目前对于参与临床研究的未成年人数量了解甚少。针对涉及未成年人的研究，对顶尖儿科医疗中心的机构审查委员会管理人员进行了调查。分析采用描述性方法，并对缺失数据使用了自适应贝叶斯自助法插补。41家儿科研究中心中的17家（41.5%）做出了回应：据估计有74204项正在进行的研究，其中29078项（39%）涉及未成年人，6574项（23%）为“高于最小风险”。未成年人占研究对象的0.7 - 287万。儿科学迫切需要一个更准确、可靠的报告系统来跟踪未成年人参与临床研究的招募、留存和参与情况。
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