Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children – CTS Journal – Wiley Online Library


Many medicines are used “off-label” in children outside the terms of the license and feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children. To optimize pediatric trial development by promoting innovative trial design, c4c set up a European multidisciplinary advice service, including the voice of young patients and families (PPI), tailored to industry and academia. A network of experts was established to provide multidisciplinary advice to trial sponsors. Twenty-four clinical and innovative methodology expert groups (>400 experts) and a PPI database of 135 registrants were established. Up to the end of September 2022, 25 advice requests have already been completed. Sponsors appreciated the advice quality and the multidisciplinary experts from different countries, including experts not known before. The c4c project has shown successful proof of concept for a service that presents a new framework to plan innovative and feasible pediatric trials.


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