Literature DB >> 23889459

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

Matti Korppi1, Pirkko Lepola, Kim Vettenranta, Seppo Pakkala, Kalle Hoppu.   

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. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Keywords:  Clinical trial; EU regulation; Paediatric medicines; Research network

Mesh:

Year:  2013        PMID: 23889459     DOI: 10.1111/apa.12372

Source DB:  PubMed          Journal:  Acta Paediatr        ISSN: 0803-5253            Impact factor:   2.299


  3 in total

1.  Sponsors meet scientists to speed pediatric medicines development.

Authors:  Jonathan M Davis; William E Smoyer; Edward M Connor; W Charles Huskins; Cindy Pastern; Mary Purucker; Elisabeth C Schrader; Cynthia R Jackson; Frederick J Kaskel; Steven Hirschfeld
Journal:  Sci Transl Med       Date:  2015-03-18       Impact factor: 17.956

2.  Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

Authors:  Emilie Desselas; Claudia Pansieri; Stephanie Leroux; Maurizio Bonati; Evelyne Jacqz-Aigrain
Journal:  PLoS One       Date:  2017-02-13       Impact factor: 3.240

3.  Does the EU's Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross-sectional study.

Authors:  Pirkko Lepola; Siri Wang; Ann Marie Tötterman; Ninna Gullberg; Kirstine Moll Harboe; Elin Kimland
Journal:  BMJ Paediatr Open       Date:  2020-12-30
  3 in total

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