Difficulties in performing clinical trials of antithrombotic therapy in neonates and children

被引：40
作者：
Massicotte, M. Patricia
Sofronas, Marianne
deVeber, Gabrielle
机构：
[1] Hosp Sick Children, Div Neurol, Toronto, ON M5G 1X8, Canada
[2] Univ Alberta, Stollery Childrens Hosp, Edmonton, AB, Canada
[3] Hosp Sick Children Res Inst, Dept Populat Hlth Sci, Toronto, ON, Canada
来源：
THROMBOSIS RESEARCH | 2006年 / 118卷 / 01期
基金：
英国医学研究理事会;
关键词：
pediatric clinical trials; antithrombotic medications; stroke; infants; children; ethics;
D O I：
10.1016/j.thromres.2005.05.020
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
The practice of evidence-based medicine is based on the results of property designed, conducted and analyzed studies. Evidence for the safety and efficacy of therapies is established through clinical trials. However, there are a number of difficulties in the design and management of clinical trials in children. We explore the theoretical and ethical issues and difficulties of designing and conducting clinical trials in children, and illustrate the ways in which these challenges were encountered in two clinical trials assessing anticoagulant therapy in children with thrombophilia (PROTEKT (PROphylaxis of ThromboEmbolism in Kids Trial) and REVIVE (REVIparin in Venous ThromboEmbolism)). Means for overcoming these challenges are also addressed. (c) 2005 Elsevier Ltd. All rights reserved.
引用
收藏
页码：153 / 163
页数：11
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