Limited impact of EU Paediatric Regulation on Finnish clinical trials highlights need for Nordic collaboration

被引：6

作者：

Korppi, Matti ^{[1
,2
]}

Lepola, Pirkko ^{[3
]}

Vettenranta, Kim ^{[4
]}

Pakkala, Seppo ^{[5
]}

Hoppu, Kalle ^{[4
,6
,7
]}

机构：

[1] Tampere Univ, Tampere Ctr Child Hlth Res, Tampere 33014, Finland

[2] Univ Hosp, Tampere, Finland

[3] Tampere Univ, Finnish Investigators Network Pediat Med, Tampere Ctr Child Hlth Res, Clin Res Inst Helsinki Univ Cent Hosp Ltd, Tampere 33014, Finland

[4] Hosp Dist Helsinki & Uusimaa HUS, Hosp Children & Adolescents, Helsinki, Finland

[5] Clin Res Inst Helsinki Univ Cent Hosp Ltd, Helsinki, Finland

[6] Univ Helsinki, Dept Clin Pharmacol, SF-00250 Helsinki, Finland

[7] Helsinki Univ Cent Hosp, Poison Informat Ctr, Helsinki, Finland

来源：

ACTA PAEDIATRICA | 2013年 / 102卷 / 11期

关键词：

Clinical trial; EU regulation; Paediatric medicines; Research network; CHILDREN RESEARCH NETWORK; MEDICINES; GLOBALIZATION; LABEL; WARDS;

D O I：

10.1111/apa.12372

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

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

引用

页码：1035 / 1040

页数：6

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