Commentary

The FIMP Medicines for Children Research Network

Ettore Napoleone^1* and Giuseppe Mele²

• * Corresponding author: Ettore Napoleone ettorenapoleone@tiscali.it

Author Affiliations

¹ Indirizzo: Piazza della Vittoria 14/A, Campobasso 86100, ITALIA

² FIMP (Italian Paediatric Federation), Via Carlo Bartolomeo Piazza, n.30, Roma 00161, ITALIA

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Italian Journal of Pediatrics 2010, 36:46 doi:10.1186/1824-7288-36-46

Published: 30 June 2010

Abstract

The European Paediatric Regulation (EUPR) calls for the fostering of high quality ethical research and medicinal products to be used in children. The EUPR provides the background, goals, and requirements for paediatric clinical trials. Paediatric clinical trials in children are mandatory to generate data on new drugs as well as on drugs used off-label or for unlicensed indications. The Family Paediatricians Medicines for Children Research Network (FIMP-MCRN) was established in 2003 with the aim of developing competence, infrastructure, networking and education for paediatric clinical trials. The network, consisting of twenty Paediatric Regional Networks has progressed very well and has achieved valuable improvements concerning the conduct of paediatric clinical trials. Furthermore, ad hoc training programs have incremented knowledge about clinical trials in Family Paediatrician Investigators (FPI) and have made medical professionals as well as the public aware of the need and advantages of trials in children.