Considerations in the rational design and conduct of phase I/II pediatric clinical trials: Avoiding the problems and pitfalls
Considerations in the rational design and conduct of phase I/II pediatric clinical trials: Avoiding the problems and pitfalls
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DOI：
10.1038/sj.clpt.6100134
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发表时间：
2007-04-01
影响因子：
6.7
通讯作者：
Kearns, G. L.
中科院分区：
文献类型：
--
作者：
Abdel-Rahman, S. M.;Reed, M. D.;Kearns, G. L.
在过去十年中，人们更加认识到需要将儿童纳入药物开发过程。随着这一认识的提高，在儿童中开展研究的基础设施得到了扩展，儿科临床试验的赞助也有所增加。然而，在许多情况下，儿科研究的增长并没有伴随着受过培训的儿科研究者参与试验设计和/或解释的增加。儿科I/II期方案继续跨越从精心构建的方案到设计不良的方案的范围。本文强调了I/II期方案的基本要素，值得独特的考虑，当临床试验涉及儿童。根据我们的经验提供了例证，突出了试验设计时未考虑到儿科患者可能出现的问题。
Over the past decade, there has been a heightened awareness of the need to include children in the drug development process. With this awareness has come an expansion of the infrastructure for conducting studies in children and an increase in the sponsorship of pediatric clinical trials. However, the growth in pediatric research has, in many cases, not been accompanied by an increase in the involvement of trained pediatric investigators when it comes to trial design and/or interpretation. Pediatric phase I/II protocols continue to span a spectrum from those that are carefully constructed to those that are poorly designed. This paper highlights the basic elements of phase I/II protocols that merit unique consideration when the clinical trial involves children. Illustrations are provided from our experience, which highlight problems that may arise when trials are not designed with the pediatric patient in mind.