Website

http://www.ecrin.org/projects/pedcrin

Role of CVBF

Partner

Description

The Paediatric Clinical Research Infrastructure Network (PedCRIN)–is a EU-funded project aimed to bring together the European Clinical Research Infrastructure Network (ECRIN) and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) to develop capacity for the management of multinational paediatric clinical trials.

It arises from the awareness that more clinical trials are required to address specific needs of the paediatric population. Children do not often receive appropriate treatments since many medicinal products have not been adequately tested or authorised for them. Moreover, the paediatric population often responds to drugs and other therapeutics differently than adults do.

There are several scientific and operational challenges for conducting paediatric clinical trials. Additionally, non-commercial trials have to face many difficulties, e.g. lack of funding, inadequate infrastructure and lack of platform to facilitate collaboration and discussion.

The aim of PedCRIN is, therefore, to develop the necessary tools and capacity to enhance the quality, safety, efficacy and ethical standards of multinational, non-commercial paediatric clinical trials.

CVBF, as partner in collaboration with the TEDDY Network, will be responsible for the creation of tools specific for paediatric trials or for the upgrade of tools and databases, already developed by ECRIN for adult trials, to take into consideration paediatric specificities.

One of the main initiatives of the project is the launching of a call supporting the multinational extension of paediatric studies on medicinal products having already secured funding in the coordinating country and to select, based on scientific excellence and evidence for feasibility, multi-national investigator-initiated paediatric or neonatal interventional clinical studies on medicinal products.

More information on PedCRIN are available in the project factsheet: http://www.ecrin.org/sites/default/files/PedCRIN/PedCRIN%20factsheet.pdf

Funds

European Union’s Horizon 2020 programme

Budget

3.3 million euro

EU Contribution

3.3 million euro

Duration

2017-2021

Partners

(1) European Clinical Research Infrastructure Network – ERIC (ECRIN-ERIC), France; (2) The University of Liverpool (ULIV), United Kingdom; (3) Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Italy; (4) Radboud University (RUMC), Netherlands; (5) Institut National de la Santé et de la Recherche Médicale (INSERM), France; (6) Hospital District of Helsinki and Uusimaa (HUS-FI), Finland; (7) Fundacio San Joan de Deu (FSJD), Spain; (8) Swiss Clinical Trial Organisation (SCTO), Switzerland; (9) Karolinska Institutet (KI), Sweden; (10) Helse Bergen HF Haukeland University Hospital (HUS-NO), Norway; (11) Tartu Ulikool (UTartu), Estonia; (12) Aristotelio Panepistimio Thessalonikis (AUTH), Greece; (13) OKIDS GmbH (OKIDS), Austria; (14) The National Children’s Research Centre (NCRC), Ireland; (15) Vereniging Samenwerkende Ouder – en Patientenorganisaties (VSOP), Netherlands.