Data sharing in paediatric clinical research – A protocol (conect4children)

Conducting clinical trials (CTs) in the paediatric population can be difficult due to ethical, regulatory, methodological, and commercial issues influencing many factors such as procedures, sample size, and company strategies. On one hand, the lack of evidence-based research and the unmet medical needs, and on the other hand, the low investment of pharma companies in paediatric research, are increasingly promoting the use of existing resources. Sharing CTs data offer many potential benefits without conducting new studies. Although strongly recommended, a few initiatives sharing CTs data in the paediatric field still exist. In the framework of Work Package 5 “Data coordinating center and data quality standards”, scouting of initiatives (such as platforms, projects, private and public initiatives of pharma industries or no-profit organization, consortium of Sponsors/Funders, databases of pharma industries, or no-profit organization, etc.) sharing CTs data, with a focus on paediatric data, will be performed following a specific protocol