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).

 

Non-industry studies

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:

TREOCAPA 

 

Paracetamol in

Premature Babies

This study will assess the effectiveness of paracetamol on the closure of the ductus arteriosus and the increase in surviving without severe morbidity in extremely premature infants. The study aims to recruit around 800 babies in 17 European countries

KD – CAAP 

 

Kawasaki Disease Coronary Artery

Aneurysm Prevention trial

This study will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study.

cASPerCF

Prospective validation & clinical evaluation of

a new posaconazole dosing regimen for children

& adolescents with cystic fibrosis and Aspergillus

The study will assess the dose of posaconazole in children and young people with Cystic Fibrosis and Aspergillus infection and aims to recruit 135 children as part of the study.

Industry studies

Our industry Proof of Viability studies will be announced shortly and will include three or four studies sponsored by industry partners.