The c4c project aims to develop a Pan European Paediatric Clinical Trial Network. As part of the development of the c4c network, a selection of Proof of Viability (PoV) studies (clinical trials) will be carried out within the c4c network to test its functionalities, and to build a more effective and sustainable network for the future.
The portfolio of Proof of Viability studies consists of three non-industry sponsored studies (due to open in 2020) and four industry sponsored studies (due to open in 2021).
The non-industry Proof of Viability studies were selected through an open call for studies that would address an unmet need identified by children, young people and clinicians. The criteria asked that studies encouraged innovative methodologies and designs and spanned multiple countries and were investigator-initiated paediatric clinical trials of medicines or investigational products. A total of 57 expressions of interest were received, resulting in 27 full applications being submitted, and following a robust selection process,11 applications were shortlisted.
The final selected c4c non-industry Proof of Viability studies includes three studies covering different diseases and age groups. These are: