Innovative clinical trial design for pediatric therapeutics.
Innovative clinical trial design for pediatric therapeutics.
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DOI：
10.1586/ecp.11.43
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发表时间：
2011-09-01
影响因子：
4.4
通讯作者：
Cohen-Wolkowiez, Michael
中科院分区：
文献类型：
--
作者：
Laughon, Matthew M;Benjamin, Daniel K Jr;Cohen-Wolkowiez, Michael
直到大约15年前，赞助者很少将儿童纳入治疗方法的开发中。美国和欧洲的立法导致了儿科试验数量的增加，具体的标签变化和剂量建议，尽管婴儿仍然是一个研究不足的群体。缺乏儿童临床试验的部分原因是在这一患者群体中进行试验面临特殊挑战。特殊人群的治疗方法，包括早产儿、肥胖儿童和接受体外生命支持的儿童，研究得更少。欧洲和美国的国家研究网络正开始利用新颖的临床试验设计来解决儿科治疗方面的一些差距。最近在儿科临床试验设计方面的创新，包括稀疏和清除抽样、群体药代动力学分析和“机会性”研究，已经解决了与儿童临床试验相关的一些历史挑战。
Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, although infants remain an understudied group. The lack of clinical trials in children is partly due to specific challenges in conducting trials in this patient population. Therapeutics in special populations, including premature infants, obese children and children receiving extracorporeal life support, are even less studied. National research networks in Europe and the USA are beginning to address some of the gaps in pediatric therapeutics using novel clinical trial designs. Recent innovations in pediatric clinical trial design, including sparse and scavenged sampling, population pharmacokinetic analyses and 'opportunistic' studies, have addressed some of the historical challenges associated with clinical trials in children.