Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
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DOI：
10.1017/s1047951115000980
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发表时间：
2015-08
影响因子：
1
通讯作者：
Li JS
中科院分区：
文献类型：
--
作者：
Hill KD;Henderson HT;Hornik CP;Li JS
美国和欧洲最近的监管举措通过显著增加资本投资和儿科试验数量，改变了儿科临床试验的格局。本文的目的是回顾这些举措对儿科心血管试验景观的影响，并与其他儿科亚专科进行比较。我们还评估了可能导致近期主要儿科心血管试验成功或失败的因素，以便为该领域未来试验的最佳设计和实施提供信息。
Recent regulatory initiatives in the United States and Europe have transformed the pediatric clinical trials landscape by significantly increasing capital investment and pediatric trial volume. The purpose of this manuscript is to review the impact of these initiatives on the pediatric cardiovascular trials landscape when compared to other pediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major pediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.