Collaborative Network for European Clinical Trials for Children

Objectives

Paediatric medicines development is embedded in the European policy, legislation and in the work of the pharmaceutical industry, but currently the potential of this effort is not realised. The conect4children (c4c) project will address the critical problems with the design, implementation and operational conduct of paediatric clinical trials, for example the fragmented and redundant efforts between sponsors, sites and countries.

Outputs

c4c will generate a sustainable infrastructure that optimises the delivery of clinical trials in children through:

  • A single point of contact for all sponsors, sites and investigators
  • Efficient implementation of trials adopting consistent approaches, aligned quality standards and coordination of sites at national and international level
  • Collaboration with specialist networks
  • High-quality input to study design and preparation through rigorous strategic and operational feasibility assessment
  • The promotion of innovative methodologies.

Key project results/activities for RECs and ethics experts

c4c (conect4children) is a large European public private project that aims to facilitate the development of new drugs and other therapies for the entire paediatric population. It builds capacity for the implementation of multinational paediatric clinical trials whilst ensuring the needs of babies, children, young people and their families are met. An important part of the project is providing advice to bring clinical and innovative methodology expertise as well as the patient and parent perspective to paediatric drug development.

This is guaranteed by a network of experts that consists of various expert groups with EUREC leading the ethics expert group. Apart from giving advice on ethics in clinical trials the ethics expert group put a focus on the exchange between YPAGs (young persons' advisory groups) and REC members.

Duration
May 2018 - December 2024

Website
www.conect4children.org

Cordis Entry
cordis.europa.eu/project/id/777389