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Networking in paediatrics: The example of the Paediatric Rheumatology International Trials Organisation (PRINTO)

机译:儿科网络:儿科风湿病国际试验组织(PRINTO)的示例

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摘要

Networking is key to overcoming the logistical, methodological and ethical problems related to the implementation of paediatric studies. The adoption of legislation to encourage paediatric clinical trials by the American and European regulatory agencies has opened a new era in the assessment of drug safety and efficacy in children. Two very large international trial networks - the Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO) - have played a critical role in the implementation of this legislation and have facilitated several successful controlled studies on the safety and the efficacy of new and old drugs in paediatric rheumatic diseases. The PRINTO and PRCSG networks can be seen as a model for international co-operation in other paediatric subspecialties.
机译:建立网络是克服与儿科研究实施有关的后勤,方法和伦理问题的关键。美国和欧洲监管机构通过了鼓励儿科临床试验的立法,为评估儿童药物安全性和有效性开辟了一个新时代。两个非常大的国际试验网络-小儿风湿病合作研究小组(PRCSG)和小儿风湿病国际试验组织(PRINTO)-在该法规的实施中发挥了关键作用,并促进了关于安全性和安全性的几项成功的对照研究新旧药物在小儿风湿病中的疗效PRINTO和PRCSG网络可以看作是其他儿科专科领域国际合作的典范。

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