At c4c-S, our network is the backbone of our mission to advance paediatric drug development. Our network is composed of two main components: Expert Groups and National Hubs. These components work together to provide comprehensive support for paediatric clinical trials across Europe.
Patient and Public Involvement (PPI) is a cornerstone of the c4c-S network. PPI ensures that the needs and perspectives of patients and their families are integrated into paediatric clinical trials. By involving PPI, c4c-S aims to create patient-centred studies that are more likely to meet the needs of the paediatric population and improve the overall quality and relevance of clinical trials.
Expert groups
The Expert Groups and their Experts are core to our Expert Advice service. We have access to over 450 clinical, methodological, and Patient and Public Involvement (PPI) experts across more than 25 medical specialties. These groups provide high-quality, independent advice on all aspects of paediatric drug development, ensuring that study designs are patient-centred and meet regulatory standards.
The roles of Experts include, but are not limited to:
- Providing expertise Offering insights and recommendations on study designs, optimal study populations, outcomes or endpoints, and regulatory responses.
- Regulatory guidance Assisting with the preparation and response to regulatory inquiries and submissions.
- Reviewing assessments Evaluating the feasibility and acceptability of study designs to ensure they meet scientific and regulatory standards.
- Involving Patients and Parents Developing tailor-made plans describing patient-parent activities, defining and developing patient-parent activities in collaboration with the sponsor, and chairing patient-parent activities.
List
National hubs
The National Hubs are an integral part of c4c-S and its services. Currently, 16 countries are under contract with c4c-S,
with more countries to follow.
- NORWAY
NORPEDMED - DENMARK
DanPedMed - THE NETHERLANDS
PEDMED-NL - IRELAND
In4kids - BELGIUM
BPCRN - FRANCE
PEDSTART - SPAIN
RECLIP - PORTUGAL
STAND4KIDS - SWITZERLAND
SwissPedNet - ITALY
INCIPIT - SWEDEN
SWEDPEDMED - ESTONIA
Estonian Paediatric Research Group - GERMANY
GermanNetPaet - POLAND
POLPEDNET - HUNGARY
MCRN – Hungary - GREECE
HELPNET
National Hubs collaborate with c4c-S and its network to achieve the objectives of c4c-S and facilitate the development and availability of new drugs and other health interventions for the paediatric population. They function as c4c-S’s local point of contact and coordinate c4c-S activities in their country, such as study information review, site identification and feasibility, and trial setup and conduct.
Their roles include, but are not limited to:
Local intelligence:
Providing local knowledge and insights to refine study designs and address country-specific challenges.
National coordination:
Collaborating with local sponsor teams, overseeing clinical sites in their country, and ensuring appropriate communication and dissemination within their site network.
Regulatory support:
Offering guidance and support for national regulatory submissions and compliance with local regulations.
National Hubs have made significant contributions to the success
of paediatric clinical trials across Europe.
Here are some of their key achievements:
National Hubs have made significant contributions to the success of paediatric clinical trials across Europe. Here are some of their key achievements:
- Efficient trial conduct: National Hubs have successfully facilitated the efficient conduct of numerous paediatric clinical trials across Europe, ensuring high-quality outcomes and adherence to regulatory standards.
- High patient retention: Through effective recruitment and retention strategies, National Hubs have achieved high patient retention rates in clinical trials, contributing to the reliability and validity of study results.
- Collaboration and integration: National Hubs have fostered collaboration and integration among various stakeholders, including sponsors, sites, and investigators, creating a cohesive and supportive environment for paediatric clinical trials.
Investigators and sites
Investigators and sites play a crucial role in the c4c-S network by conducting high-quality paediatric clinical trials. They work closely with National Hubs and Expert Groups to ensure that trials are designed and conducted in alignment with the current standard of care. They are responsible for implementing study protocols, recruiting participants, and ensuring the integrity and accuracy of trial data. The expertise and dedication of investigators and sites are essential to the success of c4c-S’s mission to advance paediatric drug development.
By leveraging our extensive network of Experts and National Hubs, c4c-S is committed to advancing paediatric drug development and ensuring that well-studied drugs are accessible to paediatric patients across Europe.
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