Novel Cross-sector Collaboration Establishes Pan European Paediatric Clinical Trial Network to Improve Infrastructure and Facilitate Development of Medicines for Children in Europe
PADOVA – 29 April 2019: The conect4children (c4c) consortium today announced the selection of its first portfolio of pan-European paediatric studies aimed at advancing the understanding of high priority medicines commonly used in babies, children and young people in Europe. The four inaugural studies will be conducted by academic institutions, in addition to three or four studies by industry partners, covering different diseases and age groups.
The study portfolio will leverage the scientific quality, rigor and capabilities of the c4c network, a global consortium of more than 30 academics, 10 industry partners and a network of more than 500 affiliated partners. The research collaboration will be used to build and implement a pan-European paediatric clinical trial network whose goal is to improve the European paediatric clinical trial infrastructure in order to facilitate the development of new, innovative and safer medicines for children in Europe.
The selected studies will implement new ways to:
- Ensure that the experiences and preferences of children and young people are reflected in clinical trial design and minimise the burden of their participation in research
- Employ cutting-edge science and implement new, innovative ways to evaluate medicines
- Demonstrate the value of collaborating across 18 countries, building on a public-private partnership that blends expertise from leading industry and academic partners.
“Building on this portfolio of paediatric research, the c4c consortium aims to enhance the competitiveness of Europe as a critical region for developing medicines for children by using existing expertise, patient access and developing common processes to be applied to disease natural history studies, registries, studies of new therapies and comparisons of existing therapies,” said Professor Mark Turner, University of Liverpool, UK. About the c4c pan-European paediatric studies:
- Paracetamol in Premature Babies: Will assess the effectiveness of paracetamol in premature babies with a patent ductus arteriosus, and aims to recruit around 600 babies as part of the study (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France entirely dedicated to human health)
- Steroids to Treat Kawasaki Disease: Will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study (Leads: Dr. Despina Eleftheriou and Prof Paul Brogan of the University College of London (UCL), an academic research institution in the UK).
- Posaconazole in Children with Cystic Fibrosis: Will assess the dose of posaconazole in children and young people with Cystic Fibrosis and infection with Aspergillus and aims to recruit 130 children as part of the study (Lead: Prof. Adilia Warris of the MRC Centre for Medical Mycology, University of Aberdeen and Ospedale Pediatrico Bambino Gesù (OPBG), a children’s hospital in Rome, Italy).
- Losartan to Treat Osteogenesis Imperfecta: Will assess losartan in children and young people with Osteogenesis Imperfecta and aims to recruit 30 children (Lead: Prof. Nick Bishop of the University of Sheffield, an academic research institution in the UK).
About Innovative Medicines Initiative and c4c This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU), Europe’s biggest Public-Private Partnership, under grant agreement No 777389. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (the European Federation of Pharmaceutical Industries and Association). Under the name c4c, the new research consortium unites pharmaceutical companies, paediatric national networks as well as EU Multinational sub-specialty Networks, large patient advocacy groups, children’s hospitals and other public research organisations from across Europe. The full list of organisations involved in the project can be found at the c4c webpage www.conect4children.org. ----------------------------------------------------
For more info on IMI visit www.imi.europa.eu and follow on Twitter at @IMI_JU. Project Office/General Enquires: Email: email@example.com
For more information about the research studies, contact: INSERM (France): Jean Christophe Roze firstname.lastname@example.org UCL (UK): Despina Eleftheriou email@example.com OPBG (Italy): Adilia Warris firstname.lastname@example.org Sheffield Children’s Hospital (UK): Nicholas Bishop email@example.com
Disclaimer This communication reflects the views of the c4c Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein H2020-JTI-IMI2-2016-10. Proposal: 777389