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European Clinical Research Infrastructure
Network (ECRIN) : operational services to the management of
multinational clinical research
jacques.demotes@ecrin.org
22 January 2019
International cooperation : industry-sponsored vs. academic trials
Atal et al. “Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials” PLoS One. 2015 Dec 14;10(12):e0145122.
ECRIN-ERIC 2013
2004 ECRIN-RKP 2006 ECRIN-TWG
2008 ECRIN-PPI
2012 ECRIN-IA
2017 PedCRIN
EU Commission funding National funding
Country National hub
National CTU Network
Host Institution (linked third
party) Czech
Republic Brno CZECRIN Masaryk
University Germany Berlin KKSN KKSN Berlin
Spain Barcelona SCReN ISCIII France Toulouse F-CRIN INSERM
Hungary Pecs HECRIN University of Pecs Ireland Dublin CRCI HRB
Italy Rome ItaCRIN ISS Norway Trondheim NORCRIN St Olaf Hospital Portugal Lisbon PtCRIN Nova University Slovakia Kosice SlovaCRIN Kosice University
Switzerland Berne SCTO SCTO
Members / Observers
ECRIN Members / Observers and national scientific partners
Distributed infrastructure, providing distributed services
5
6
ECRIN operational support -> Collaboration Committee
1 – Support to planning / design / funding -> Peer Review Committee
2 – Protocol peer review, risk assessment 3 - ECRIN operational services Distributed services
regulatory-ethics approvals study monitoring
Central services pharmacovigilance data management
ECRIN tools
guidance on methodology / design
regulatory / ethics database (‘Campus’) risk-based monitoring toolkit
data centre certification data sharing
Operational services, and tools for multinational trials
> 50 trials, mean 6 countries per trial
ECRIN trial portfolio
8
0
5
10
15
20
25
30
35
Trials Portfolio (Nov 2017)
coordinating country participating country
9
Funding for multinational trials
10
Partnership with medical specialty / investigation networks EBRA
ECRAID TRANSVACPedCRIN c4c EPTRI EJP-RD TB-Med
11
Protocol design Site selection patients ? investigator ?
Patient selection Informed consent Data from cohorts / registries Electronic health records Electronic data capture Data from national databases Data sharing for meta-analyses,
re-analyses, secondary use
Data reuse High-throughput –omics Imaging data Patient stratification studies Multimodal data management AI algorithms
Digital revolution in clinical research European Open Science Cloud, Health Research and Innovation Cloud
Lancet 390:2137 (2017)
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Clinical Research Initiative for Global Health Secretariat NIH + ECRIN (OECD and WHO partners)
6 projects Infrastructure and funding Global core competencies Research ethics Patient involvement Comparative effectiveness research Data management and data sharing
International cooperation : CRIGH
www.crigh.org Nature 545:289 (2017)
Clinical Operations Unit : Head of Unit : Sabine Kläger sabine.klager@ecrin.org Project Manager: Marta Del Alamo marta.delalamo@ecrin.org European Correspondents Czech Republic : Lenka Souckova/ Katerina Nebeska France : Amélie Michon / Luc Wasungu Germany : Linda Stoehr / Laura Vieweg Hungary : Zita Tarjanyi Ireland : Suzanne Bracken / Fiona Cregg Italy : Elena Toschi Norway : Valentina Iversen Portugal : Catarina Madeira Slovakia : Stefan Toth / Simona Sonderlichova Spain : Juan Ferrero Switzerland : Caecilia Schmid
Contacts (www.ecrin.org)
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