Failed Pediatric Drug Development Trials
Failed Pediatric Drug Development Trials
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DOI：
10.1002/cpt.142
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发表时间：
2015-09-01
影响因子：
6.7
通讯作者：
Burckart, G. J.
中科院分区：
文献类型：
--
作者：
Momper, J. D.;Mulugeta, Y.;Burckart, G. J.
儿科产品开发计划刺激了儿童治疗的开发，从而改善了产品标签，增加了不良事件的识别，并开发了新的儿科制剂。然而，最近完成的儿科试验中有42%未能确定安全性或有效性，导致无法将产品标记为用于儿童。(1)描述这些失败的试验，包括常见的影响因素，对于未来设计更好的儿科试验至关重要。
Pediatric product development initiatives have stimulated the development of therapies for children, resulting in improved product labeling, increased identification of adverse events, and development of new pediatric formulations. However, 42% of recently completed pediatric trials have failed to establish either safety or efficacy, leading to an inability to label the product for use in children.(1) Characterizing these failed trials, including common contributing factors, is imperative to designing better pediatric trials in the future.