Record #202513 - GSI Repository

PedCRIN

Paediatric Clinical Research Infrastructure Network

Coordinator	National Children’s Research Centre ; University of Liverpool ; Inserm ; Karolinska Institutet Innovations (Sweden) ; Swiss Clinical Trial Organisation (SCTO) ; University of Tartu ; STICHTING KATHOLIEKE UNIVERSITEIT ; Vereniging Samenwerkende Ouder- en Patiëntenorganisaties ; Consorzio per Valutazioni Biologiche e Farmacologiche ; ARISTOTELIO PANEPISTIMIO THESSALONIKIS ; ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ; FUNDACIO SANT JOAN DE DEU ; HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL ; Hospital District of Helsinki and Uusimaa ; OKIDS GMBH
Grant period	2017-01-01 - 2021-06-30
Funding body	European Union
Call number	H2020-INFRADEV-2016-1
Grant number	731046
Identifier	G:(EU-Grant)731046

Note: 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.

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Record created 2017-06-14, last modified 2023-02-08

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