Many medicines available to children are used “off-label” which means the medicines have not been tested specifically with children in clinical trials. To change this, in 2007, the Paediatric Regulation was implemented to support medicines development for children. There are now large numbers of trials in children, both planned and ongoing. However, the research infrastructure to carry out these trials has not developed as quickly or consistently across Europe. This has led to delays in completing clinical trials and often delays in the availability of medicines approved for use in children. c4c is tackling this issue and working to facilitate clinical trials across Europe to support the development of new drugs and other therapies for the entire paediatric population.
What is c4c?
Collaborative Network For European Clinical Trials For Children
c4c is a large collaborative paediatric network facilitating the development of new drugs and other therapies for the entire paediatric population in Europe. The consortium is a novel collaboration between academic and private sectors that includes 35 academic and 10 industry partners, more than 50 third parties and around 500 affiliated partners.
The six-year project, comprises of a multidisciplinary public-private consortium, bringing 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 remain central. Strong links with regulators are being established.
Penta is the coordinator of the c4c project.
Why is c4c needed?
Across Europe, the research infrastructure to support the delivery of large clinical trials hasn’t been developed equally. Clinical trials are often delayed, and the rollout of medicines approved for children is slow. Building paediatric clinical research networks and infrastructure can facilitate the generation of information needed to ensure that the right drug at the right dose is available for the use for children and newborns.
What is c4c’s goal?
The c4c consortium aims to develop a large, collaborative paediatric network that will facilitate the development of new drugs and other therapies for the entire paediatric population in Europe.
c4c will use a coordinated approach to deliver high quality “regulatory grade” clinical trials in:
- Multiple countries
- Multiple sites
- All paediatric age groups by supporting,
- Trial implementation using resources shared between studies
- Trial design through a combination of information about natural history, feasibility, appropriate innovation, and expert opinion
- Education and awareness within and beyond the network
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
