"Common sense is hard work" but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines.

ABSTRACT:

Introduction

The Collaborative Network for European Clinical Trials for Children (c4c) is a public private partnership with a developed infrastructure across European sites to support the design and conduct of multi-national academic and industry paediatric clinical trials. This paper aims to review the learning points identified during co-development of c4c processes by academic and industry partners.

Methods

Study metrics were recorded. Learning points were captured during network development, categorized and included in a thematic analysis from which lessons learnt were identified.

Results

12 trials were supported by sites coordinated at national level and integrated at European level. A total of 9 CDA cycles were completed, resulting in 436 site CDAs signed in a m

SUBMITTER: Attar S 

PROVIDER: S-EPMC11850778 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature