Clinical Report-Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
Clinical Report-Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
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DOI：
10.1542/peds.2010-0082
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发表时间：
2010-04-01
期刊：
影响因子：
8
通讯作者：
Denne, Scott C.
中科院分区：
文献类型：
--
作者：
Shaddy, Robert E.;Denne, Scott C.
在儿童中评价药物的研究的适当道德行为对所有参与这类研究的人来说至关重要。本报告是对1995年美国儿科学会先前发表的指南的更新修订。自上次出版以来，在儿童药物研究的科学和伦理方面取得了巨大进步。还有许多立法和监管方面的进步，促进了对儿童药物的研究，同时也允许保护这一特别脆弱的群体。本报告总结了这些变化和进展，并提供了一个框架，从该框架指导和监督研究的道德行为，以评估儿童药物。儿科2010; 125：850-860
The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children. Pediatrics 2010; 125: 850-860