The pressing need for medicines research for children needs to be addressed by multistakeholder-research networks. Over the last seven years, an integrated, pan-European clinical trial network was built, to facilitate the planning and conduct of high quality clinical trials for the entire paediatric population, whilst ensuring that the voices of young patients and their families are heard.
The conect4children c4c project, funded by the Innovative Medicines Initiative (IMI), was a collaborative consortium of 46 organisations from academia and industry. The seven year project completed on 30th April 2025, with many achievements including:
- The development and successful implementation of 20 National Hubs across 21 European countries. These National Hubs coordinate activities across sites within their network to ensure the successful and smooth running of high-quality paediatric clinical trials.
- Implementation of Industry and non-Industry Proof of Viability Studies using c4c infrastructure. These studies were conducted to test the functionality and services developed by c4c, and to build a more effective and sustainable network for the future.
- The development and launch of the Strategic Feasibility Advice Service, which includes over 450 experts. This service brings clinical and innovative methodology expertise as well as the patient and parent perspective to paediatric development.
- Establishment of the c4c Education and Training Academy offering a variety of courses, including GCP and GCP related courses, to paediatric clinical trial staff. The purpose of the c4c Academy is to educate and upskill paediatric clinical trial staff.
- Organisation of 6 Multistakeholder Meetings. These meetings are designed to facilitate constructive interactions between relevant stakeholders (patients/patient representatives, clinicians, academics, pharmaceutical companies and regulators) in a pre-competitive setting to define unmet medical needs, to define how best to address those needs and facilitate the development of innovative medicines.
- In collaboration with CDISC, developed the Pediatric User Guide aimed at standardising paediatric data items used in clinical trials.
- Roll out of services through the conect4children Stichting (c4c-S) to ensure that c4c can continue to support the development of better treatments for babies, children and young people.
The conect4children Stichting (c4c-S), a Dutch non-profit organisation, will continue the c4c project mission to bring better medicines to babies, children and young people.
c4c-S offers industry and academia rapid, timely insights to support design and implementation of paediatric clinical trials:
- Expert Advice about paediatric drug development (within 3 months)
- Site finding (within 2 weeks) and protocol-driven feasibility (within 4 weeks)
For further information about c4c-S services: https://conect4children.eu
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conect4children Stichting
To ensure that the network and the achievements of the c4c project would be sustained, c4c-S was established in 2023 within the c4c project to continue to address the challenges of conducting paediatric trials by fostering an environment where patients, parents, and the medical community work closely together.
Today, c4c-S is fully operational and offers the services listed below through their single point of contact (SPoC):
- Expert Advice
- Site Identification
- Site Feasibility
>To keep up to date with the progress of c4c-S, you can subscribe to their newsletter here.
>To contact c4c-S please send an email to c4c.spoc@conect4children.eu
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About c4c: “Better medicines for babies, children and young people through a pan-European
clinical trial network”
c4c (conect4children) was a large collaborative paediatric network that facilitated the development of new drugs and other therapies for the entire paediatric population in Europe.
It built capacity for the implementation of multinational paediatric clinical trials whilst ensuring the needs of babies, children, young people and their families were met.
c4c provided a sustainable, integrated infrastructure for the efficient and swift delivery of high-quality clinical trials in children and young people across all conditions and phases of the drug development process.
By emphasizing inclusiveness and collaboration across geographical, specialty, sectoral, cultural and societal backgrounds, c4c improved the infrastructure to support the development of medicines for children.
>For further information, please follow the link to the c4c website: https://conect4children.org/
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About the c4c Consortium
The c4c research Consortium brings together pharmaceutical companies, paediatric national networks as well as EU multinational sub-speciality 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 include 36 academic and 10 industry partners from 20 European countries.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU), Europe’s biggest Public-Private Partnership, under grant agreement No 777389. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (the European Federation of Pharmaceutical Industries and Association).
>A list of c4c Beneficiaries is available to view here: https://conect4children.org/network/
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About the National Hubs
There are 20 National Hubs in c4c’s map.
The c4c National Hubs (NHs) are central to the research infrastructure that the consortium is developing. The role of the c4c NHs are to act as the national contact point to liase between the c4c network and participating sites (third parties) in each country. The NHs offer assistance with feasibility and site set-up to support the conduct of proof-of-viability (PoV) studies to prime and test the organization.
Some NHs are hosted by their pre-existing National Network (NN) and will work with all eligible sites in their country. The dimension, maturity and scope of activity and services of existing NNs outside of c4c activities is heterogeneous.
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About the c4c pan-European Academic Paediatric Studies
- TREOCAPA – Paracetamol in Premature Babies: assessed the effectiveness of paracetamol on the closure of the ductus arteriosus and the increase in survival without severe morbidity in extremely premature infants. The study aimed to recruit around 800 babies across 17 European countries. (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France, entirely dedicated to human health)
- KD-CAAP – Kawasaki Disease Coronary Artery Aneurysm Prevention trial: assessed the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aimed to recruit 262 children as part of the study. (Leads: Dr. Despina Eleftheriou and Prof. Paul Brogan of University College London (UCL), an academic research institution in the UK)
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Further information
For more info on IMI visit www.imi.europa.eu / https://www.ihi.europa.eu/
Project Office/General Enquires: Email us at communication@conect4children.org
INSERM (France): Jean Christophe Roze: jcroze@chu-nantes.fr
UCL (UK): Despina Eleftheriou: d.eleftheriou@ucl.ac.uk
Disclaimer
This communication reflects the views of the c4c Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein
H2020-JTI-IMI2-2016-10. Proposal: 77738
Please note that from 30 April 2025 the project will be closed.
To keep in contact please contact: c4c.spoc@conect4children.eu
