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欧盟儿科法规对芬兰临床试验的影响有限,凸显北欧合作的必要性。

Limited impact of EU paediatric regulation on Finnish clinical trials highlights need for Nordic collaboration.

机构信息

Tampere Center for Child Health Research, Tampere University and University Hospital, Tampere, Finland.

出版信息

Acta Paediatr. 2013 Nov;102(11):1035-40. doi: 10.1111/apa.12372. Epub 2013 Aug 19.

Abstract

UNLABELLED

The Finnish Investigators Network for Paediatric Medicines (FINPEDMED) was established in 2007, to meet the expected increase in paediatric clinical trials following the new EU Paediatric Regulation. Between 2007 and 2012, FINPEDMED received 91 trial requests, 18 trials were started, and in 24 cases, Finnish investigators were not selected by sponsors.

CONCLUSION

This experience from Finland highlights the need for Nordic collaboration to increase expertise, recruitment base and attractiveness for sponsors.

摘要

目的

芬兰儿科药物研究人员网络(FINPEDMED)成立于 2007 年,旨在满足新的欧盟儿科法规实施后预期增加的儿科临床试验需求。2007 年至 2012 年期间,FINPEDMED 共收到 91 项试验申请,启动了 18 项试验,但在 24 例中,申办者未选择芬兰研究者。

结论

芬兰的这一经验强调了北欧合作以提高专业知识、招募基础和对申办者吸引力的必要性。

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