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Better medicines for babies, children and young people through a pan-European clinical trial network



c4c will use a coordinated approach to deliver high quality “regulatory grade” clinical trials in:

  • Multiple countries
  • Multiple sites
  • All paediatric age groups

The pan-EU Paediatric Clinical Trial Network

A project under the EU Innovative Medicines Initiative (IMI)

  • Ensure efficacy, safety & quality of health products
  • Reduce time to clinical proof of concept
  • Improve the current drug development process
  • Develop new therapies for diseases with high unmet need & limited market incentives
  • Allow engagement in a cross-sector, multi-disciplinary consortium at the forefront of cutting-edge research
  • Ensure the voice of patients is heard to safeguard better treatments for children

Key Objectives

  • More efficient trial implementation through the set-up of national hubs and qualified sites
  • Input in clinical trial design and implementation from pilot expert advisory groups and other fora
  • Educational programme for health professionals and awareness raising campaigns for the general public
  • Identification of Data standards and performance metrics
  • Business cases for sustainability beyond IMI funding

Key Features

  • International network with lean central coordination
  • A single point of contact (One-stop-shop)
  • Efficient implementation of trials
  • Consistent procedures across sites
  • Strategic and operational feasibility assessment
  • Involvement of experts to develop innovative trial designs and methodology
  • Multi-KEY stakeholder collaboration

Benefits for the paediatric community

  • Harmonized, streamlined procedures across the trial lifecycle
  • Opportunities to build economies of scale at site and national level
  • Reducing barriers to entry and so making paediatric research more attractive and competitive
  • Access to a wide range of study sponsors through a transparent, evidence-based, network-wide vetting procedure
  • Input from relevant specialty networks and methodologists on study design, implementation and assessment
  • The specific medical needs of children at the foreground

Expected long term impact of c4c

  • Access to new experimental therapies for children in well-designed clinical trials
  • Better training for research personnel and improved trial readiness at all participating sites
  • Improved efficiency in executing trials (faster, cheaper)
  • Improved data quality for labelling of next generation medicines for children
  • Enhanced role of clinicians and patient/parent advocacy groups in planning and designing studies
  • Broadening the access of academic medical centers and clinical faculty across Europe to new experimental therapies

Private-public partnership between Academia and Pharma

The c4c research network brings together 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 project consortium is a novel collaboration between academic and private sectors that includes 33 academic and 10 industry partners from 20 European countries, as well as more than 50 third parties and around 500 affiliated partners.

The c4c consortium members

  • 10 EFPIA companies
  • 18 paediatric national networks
  • 2 large patient advocacy groups
  • 8 EU multinational specialty networks
  • 3 global research networks
  • 2 large children’s hospitals

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.