Role of CVBF
The “conect4children” (collaborative network for European clinical trials for children) (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.
The consortium is a novel collaboration between academic and private sectors that includes 33 academic and 10 industry partners from 20 European countries, more than 50 third parties and around 500 affiliated partners.
The six-year project, comprised of a multidisciplinary public-private consortium, brings together key stakeholders across academia and industry. It is a pioneering opportunity to build capacity for the management of multinational paediatric clinical trials across Europe whilst ensuring the voices of children, young people and their families are heard. Strong links with regulators will be established.
This project aims to generate a sustainable infrastructure that optimises the delivery of clinical trials in children through:
- a single point of contact for all sponsors, sites and investigators
- efficient implementation of trials adopting consistent approaches, aligned quality standards and coordination of sites at national and international level
- collaboration with specialist and national networks
- high quality input to study design and preparation through rigorous strategic and operational feasibility assessment
- the promotion of innovative trial design and quantitative science methods
- an education and training platform to shape the future leaders of paediatric drug development
- the development of sustainable support for all these activities
One of the key goals of the project is to support the use of innovative trial designs and new quantitative methods to foster development of new innovative medicines and to support development in rare paediatric diseases and high medical need area.
IMI2 (Innovative Medicines Initiative) Call 10
140 Million Euro
IMI2 support of 67 Mio€ and industry partners’ in-kind contribution of 73 Mio€
Fondazione PENTA, The University of Liverpool, Ospedale Pediatrico Bambino Gesù, EURORDIS – European Organisation for Rare Diseases Association, European Cystic Fibrosis Society, Stichting Katholieke Universiteit, Swiss Clinical Trial Organisation Verein, Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Istituto Giannina Gaslini, University College London, SIOP Europe ASBL, Tartu Ulikool, Okids GMBH, University of Newcastle upon Tyne, Universiteit Gent, Universitaetsklinikum Heidelberg, Aristotelio Panepistimio Thessalonikis, Instytut Pomnik Centrum Zdrowia Dziecka, Helse Bergen HF*Haukeland University Hospital, ECNP Research & Scholarship Foundation, Robert Bosch Gesellschaft fur Medizinische Forschung MBH, University College Cork, Karolinska Institutet, Fundacio Sant Joan de Deu, Servizo Galego de Saude, Gyermekgyógyászati Klinikai Vizsgálói Hálózat, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (member of CVBF), ECRIN European Clinical Research Infrastructure Network, The Hospital District of Helsinki and Uusimaa, Institut National de la Sante et de la Recherche Medicale, Helios Dr. Horst Schmidt Kliniken Wiesbaden Gmbh, ARSENAL.IT-Centro Veneto Ricerca e Innovazione per la Sanità Digitale, Univerzita Karlova, Janssen Pharmaceutica NV, Bayer Aktiengesellschaft, Sanofi-Aventis Recherche & Developpement, Eli Lilly and Company Limited, UCB Biopharma SPRL, Novartis Pharma AG, Institut de Recherches Internationales Servier, GlaxoSmithKline Research and Development LTD, Pfizer Limited, F. Hoffmann – La Roche AG.