23 Sep, 2014
Authors: Ruggieri L., Giannuzzi V., Baiardi P., Bonifazi F., Davies E.H., Giaquinto C. , Bonifazi D., Felisi M., Chiron C., Pressler R., Rabe H., Whitaker M.J., Neubert A., Jacqz-Aigrain E., Eichler I., Turner M.A., Ceci A; GRiP Consortium.
Published in: Eur J Pediatr. 2015, 174: 481-91.
Abstract: The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.