PRESS RELEASE
21 MAY 2018
Launch of a new public-private partnership to improve clinical trial infrastructure to facilitate the development of new drugs for children in Europe.
The members of the “conect4children” (c4c) initiative today announced the start of a large collaborative paediatric network that will facilitate the development of new drugs and other therapies for the entire paediatric population in Europe. 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. There are many scientific and operational challenges faced by both pharmaceutical companies and academia when running paediatric clinical trials. According to Prof. Carlo Giaquinto of Fondazione PENTA Onlus and University of Padova, who coordinates the project, “c4c will address critical problems with the design, implementation and operational conduct of paediatric clinical trials, such as fragmented and redundant efforts between sponsors, sites and countries; the paucity of patients available for study in many paediatric indications and the need for multiple capable sites and expertise to make trials successful.” 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
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