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Project

PedCRIN

Title Paediatric Clinical Research Infrastructure Network
Grant Agreement Number 731046
Funding Programmes H2020
Budget Total: €3,296,000.00, EC Contribution: €3,296,000.00
Dates 01/01/2017 - 31/12/2020
Type Of Project CSA
Abstract Children’s health is a major societal challenge for Europe and the world, requiring development of paediatric medicines and treatments strategies based on evidence derived from clinical trials demonstrating efficacy and safety in infants and children, rather than on uncritical extrapolation from adult data (over 50 % of the medicines used for children had not been tested in this specific age group). Conducting clinical trials in children requires specific competences and infrastructure. ECRIN-ERIC (www.ecrin.org) is a generic infrastructure for multinational trial management, in any disease area. However it does not specifically address the paediatric needs in terms of trial management capacity. In its 2016 Roadmap, ESFRI suggested an upgrade of ECRIN to develop a common infrastructure for paediatric trial management through cooperation with the European Paediatric Clinical Trial Research Infrastructure (EPCTRI). The resulting PedCRIN project is also a unique opportunity to improve ECRIN business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries. PedCRIN builds on five work packages : project coordination (WP1); establishment of a strategy and upgrade of the governance and business plan, through a Sustainability Board jointly involving the scientific partners and the government representatives (WP2); development of tools specific for paediatric and neonatal trials (WP3) (methodology, outcome measures, adverse event reporting, bio-sample management, ethical and regulatory database, monitoring, quality and certification); operational support provided as transnational access to a few pilot trials to test the updated organisation and tools (WP4); communication targeting user’s communities (including industry), policymakers, patient and parents’ empowerment (WP5). Two other ESFRI-landmarks, BBMRI-ERIC and EATRIS ERIC, will contribute to PedCRIN.
Coordinator
(Organisation name and Country, EC contribution to budget) 		ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK, France, (€1,535,125.00)
Partners
(Organisation name and Country, EC contribution to budget) 		KAROLINSKA INSTITUTET, Sweden, (€48,750.00)
ARISTOTELIO PANEPISTIMIO THESSALONIKIS, Greece, (€48,750.00)
TARTU ULIKOOL, Estonia, (€48,750.00)
VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES, Netherlands, (€185,625.00)
SWISS CLINICAL TRIAL ORGANISATION VEREIN, Switzerland, (€48,750.00)
STICHTING KATHOLIEKE UNIVERSITEIT, Netherlands, (€203,125.00)
THE UNIVERSITY OF LIVERPOOL, United Kingdom, (€325,875.00)
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ, Finland, (€178,125.00)
HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL, Norway, (€48,750.00)
THE NATIONAL CHILDREN'S RESEARCH CENTRE, Ireland, (€48,750.00)
OKIDS GMBH, Austria, (€48,750.00)
FUNDACIO SANT JOAN DE DEU, Spain, (€178,125.00)
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE, Italy, (€170,625.00)