Paediatric Clinical Research Infrastructure Network

akronüüm: PedCRIN
algus: 2017-01-01
lõpp: 2020-12-31
 
programm: H2020 - Horisont 2020
alaprogramm: INFRA - Euroopa Teadustaristud, sh e-Taristud
instrument: CSA - Koordineeriv ja toetav tegevus
projektikonkurss: H2020-INFRADEV-2016-1
projekti number: 731046
kestus kuudes: 48
partnerite arv: 15
 
lühikokkuvõte: 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.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR DEMOTES JACQUES www.ecrin.org
2 partner THE UNIVERSITY OF LIVERPOOL UK www.liverpool.ac.uk
3 partner CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE IT www.cvbf.net
4 partner STICHTING KATHOLIEKE UNIVERSITEIT NL www.ru.nl
5 partner INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR www.inserm.fr
6 partner HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI www.hus.fi
7 partner FUNDACIO SANT JOAN DE DEU ES www.fsjd.org
8 partner SWISS CLINICAL TRIAL ORGANISATION CH www.scto.ch
9 partner KAROLINSKA INSTITUTET SE www.ki.se
10 partner HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL NO http://www.helse-bergen.no/
11 partner Tartu Ülikool EE www.ut.ee
12 partner ARISTOTELIO PANEPISTIMIO THESSALONIKIS - EIDIKOS LOGARIASMOS KONDILION EREVNAS EL www.auth.gr
13 partner OKIDS GMBH AT www.okids-net.at
14 partner THE NATIONAL CHILDREN'S RESEARCH CENTRE IE http://www.nationalchildrensresearchcentre.ie/
15 partner VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES NL www.vsop.nl