Traditionally children and young people have been excluded from participating in clinical trials or have not had the opportunity to be involved in the design of clinical studies. However, this doesn’t mean that involving paediatric patients is not feasible and involving patients does have important benefits. It’s time to shift from a drug-centric approach towards…
From left to right: Laura Persijn, Dr. Sevasti Karamaria, Prof. Dr. Ann Raes, Daphné Christiaens, Dr. Lieve Nuytinck, Dr. Eva Degraeuwe, Prof. Dr. Johan Vande Walle After three years of hard work, we are proud to present the progression and the situation we position ourselves in today. Before conect4children (c4c), the sites within our…
The conect4children project (c4c) is working to facilitate clinical trials across Europe to support the development of new drugs and other therapies for the entire paediatric population. In addition to the technical and operational improvements needed to achieve this goal, we also want to raise the general public’s awareness about the importance of paediatric clinical…
In a conventional clinical trial, adult or paediatric, typically half of the participants receive the drug under investigation and half receive placebo or standard of care. If there are many trials in a disease area, it can be hard to find enough patients for all the trials taking place at a given time. Trials may…
What is conect4children? [Video] Better medicines for babies, children and young people Thanks to the joint forces of both academic and industry partners, the Pan-European network, c4c aims to accelerate the development of innovative medicines for the entire paediatric population. c4c listens to the voices of children, young people, and their families, and is committed…
First c4c Multi-Stakeholder Meeting on Paediatric Inflammatory Bowel Disease (IBD) More than 100 stakeholders from academia, industry, regulators and patients/patient associations attended our first Multi-Stakeholder Meeting (MSM) on April 14 and 15, 2021. Background MSMs are designed to facilitate discussion and interaction among relevant stakeholders on the development of medicines in the best interest of children…
Strategic feasibility expert advice groups One of the key activities of c4c is to set up an advice process to facilitate expert advice, (Strategic Feasibility Advice) to c4c industry and academic beneficiaries on any aspect of a paediatric drug research and/or development project (e.g., study design including methodology, assistance with regulatory responses). More than 300…
Patient and Public Involvement (PPI) The voice of the patient in clinical research and development is increasingly being included, from the setting of research priorities through to the dissemination of results. This marks a shift in what has historically and culturally been, until relatively recently, research “on” rather than “with” patients. Previously, researchers defined their…
What are the c4c National Hubs (NHs)? Paediatric research has multiple challenges and these challenges become obstacles when the research infrastructure is not well-prepared to overcome them. There is a huge need to work in a coordinated way, between multiple partners and countries, to improve the design and implementation of paediatric trials. c4c has sought…
Introducing the c4c project leadership team: Carlo Giaquinto (Penta – project coordinator) Mark Turner (University of Liverpool – co-coordinator) Katharine Cheng (Janssen – project lead) Heidrun Hildebrand (Bayer – co-project lead). We lead and supervise the overall progress of c4c, with the support of the project management office, and by working closely with Work Package…