School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Expert Rev Clin Pharmacol. 2011 Sep;4(5):643-52. doi: 10.1586/ecp.11.43.
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.
大约 15 年前，赞助商很少将儿童纳入治疗药物的研发。美国和欧洲的立法规定增加了儿科试验的数量，以及特定的标签变更和剂量建议，尽管婴儿仍然是一个研究不足的群体。儿童临床试验的缺乏部分归因于在该患者人群中进行试验的具体挑战。在特殊人群中使用的治疗方法，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开始使用新的临床试验设计来解决儿科治疗中的一些空白。儿科临床试验设计的最新创新，包括稀疏和采集采样、群体药代动力学分析和“机会主义”研究，解决了与儿童临床试验相关的一些历史挑战。
