Paediatric clinical trials face several challenges, such as developing age-specific formulations and dosages, complying with regulatory requirements, ethical considerations, and the need to standardise paediatric data.

Trial sponsors develop unshared data dictionaries, making interoperability difficult and reducing the efficiency of trial’s execution.

To address these challenges, the European conect4children (c4c) network developed a cross-cutting paediatric data dictionary (CCPDD), focused on disease-independent data elements routinely collected for clinical research.

The dictionary was built over three steps: preparation (scoping) by sending a brief survey to ten c4c pharmaceutical industry partners to evaluate their interest; generation of the long-list of paediatric-relevant data elements and consensus building. Its ongoing implementation has the potential to facilitate the acquisition of standardized data, promoting interoperability across diverse trials, and simplifying the sharing of valuable insights throughout the network.

By standardizing data collection and analysis, the consortium aims to improve the quality and reliability of paediatric clinical research and accelerate the development of new treatments for children.

Our Project Development Manager, Claudia Pansieri, collaborated in the publication of this paper.