Public disclosure of clinical trials in children

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• 作者：Clavenna ; Antonio ; Pandolfini ; Chiara ; Bonati ; Maurizio
• 关键词：clinical trial ; comparative study ; child ; therapeutics ; literature review ; European Union
• 刊名：Current Therapeutic Research
• 出版年：2002
• 出版时间：October, 2002
• 年：2002
• 卷：63
• 期：10
• 页码：707-716
• 全文大小：677 K

文摘

Background: Although randomized controlled trials (RCTs) are considered the most reliable way to assess a drug's safety and effectiveness, they are not always necessary or feasible for assessing the effects of health care on pediatric patients. Recent legislation passed in the United States has led to an increase in the number of RCTs in pediatric populations, but the drugs studied in these trials have not always proven useful to pediatric patients.