The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children

Area of Science:

• Paediatric medicine
• Clinical trial management
• Regulatory science

Background:

• The European Paediatric Regulation (2007) highlighted the need for better paediatric drug information.
• A 2017 review identified significant barriers in paediatric clinical trials, including delays and country-specific variations.
• Existing challenges in paediatric research necessitate improved collaborative frameworks.

Purpose of the Study:

• To describe the conect4children (c4c) initiative, a network designed to overcome difficulties in paediatric clinical trial design and conduct.
• To outline the structure and components of the c4c consortium, funded by the Innovative Medicines Initiative (IMI2).
• To introduce a phased approach demonstrating the network's viability through pilot studies.

Main Methods:

• Establishment of a public-private consortium (c4c) with harmonised procedures and a central European point of contact.
• Provision of expert advice on study design, paediatric development programmes, and patient involvement.
• Development of a training facility for trial sites and teams, alongside data management support and a common data dictionary.

Main Results:

• The c4c network offers expert guidance, harmonised site procedures, and educational resources for paediatric trials.
• Pilot studies (proof-of-viability) are being conducted to demonstrate the network's effectiveness.
• A co-design approach involving industry and academia is central to the c4c's operational scope.

Conclusions:

• The c4c initiative addresses key challenges in paediatric clinical research, aiming to improve efficiency and collaboration.
• A sustainable successor organization is planned to ensure continued support for paediatric trials beyond IMI2 funding.
• The network's phased implementation and co-design strategy are crucial for its success in advancing paediatric drug development.