Transcript Document

European Clinical Research
Infrastructure Network
ECRIN
Pierre Lafolie, Karolinska Trial Alliance
Overview
RKP 2004-2006
(Reciprocal Knowledge Programme)
TWG 2006-2008
(Transnational Working Groups)
PPI 2008-2011
(Preparatory Phase for the Infrastructure)
RKP 2004-2006
• FP6
• Gap analysis
• Comparative analysis on bottlenecks in clinical
research following implementation of CT DIR 2001:20
Participating countries
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Denmark
France
Germany
Italy
Spain
Sweden
Output
Report to the Commission on national differences on:
1 - Structures and objectives of centres and networks
2 - Financing, sponsoring
3 - Ethics
4 - Legislation, regulatory affairs, GCP, insurance
5 - Adverse event reporting, drug dispensing
6 - Methodology, data management, data monitoring
7 - Quality management, SOPs, audits
8 - Communication, partnerships
9 - Study registers
10 - Education and careers
TWG 2006-2008
• FP6
• Description of tools to overcome gap
• Working parties accorded to needs described in RKP
• Deliverable to the Commission until September 2008
TWG, Aim
Provide integrated, ‘one-stop shop’ services to
investigators and sponsors in multinational studies
and facilitate interaction with ethics committees and
competent authority, vigilance, monitoring and data
management in pan-European studies.
Participating Countries
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Austria
Denmark
Finland
Germany
Hungary
Ireland
Italy
Spain
Sweden
Switzerland
UK
Partners to TWG
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European Forum for Good Clinical Practice (EFGCP), Belgium
Europea, Belgium
Telematikplattform, Germany
Ministère de la Recherche, France
Ministère de la Santé, France
Agency for Science, Technology and Innovation, Denmark
Science Foundation of Ireland
Department of Health, UK
Ministry of social affairs and health, Finland
Bundesministerium für Wissenschaft und Forschung, Austria
Vinnova, Sweden
Ministerio de Educacion y Ciencia, Spain
Federal Science Policy Office, Belgium
TEKES, Finland
EORTC (European Organisation for Research and Treatment of Cancer)
National Research Networks
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Medical University of Vienna (ATCRIN)
Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Rigsharpitalet, Copenhagen
University Hospital, (DCRIN)
Kuopio Innovation OY (KUoINNO)
Institut National de la Santé de la Recherche Médicale (Inserm)
Netzwerk der Koordinierungszentren für Klinische Studien (KKS)
Bundesministerium für Bildung and Forschung (BMBF)
Ministry of Health Social And Family Affairs, Hungarian ECRIN Committee, Medical research council
(HECRIN)
Dublin Molecular Medicine Centre (ICRIN)
Health Research Board (HRB)
Consorzio Italiano per la Ricerca in Medicina (CIRM)
Istituto di Ricerche Farmacologiche Mario Negri (IRFMN)
Instituto Superiore di Sanita (ISS)
Hospital Clinic I Provincial (SCReN)
Spanish Medicines Agency and Medical Devices (AEMPS)
Instituto de Salud Carlos III (ISCIII)
Karolinska University Hospital (Swecrin)
Universitat Bern (UBERN)
University of Leeds (UKCRN)
Medical Research Council (MRC)
Working party 1 on Ethics
Chairs Xavier Carné, Frank Wells
• National differences in the assessment of clinical
research protocols by ethics committees
• SOPs on:
- Informed consent sheet
- Interaction with the ethics committees
- Personal data protection
Working party 2 on Regulation
Chairs Christian Gluud, Jacques Demotes
• National differences in the regulatory framework of clinical
research, for all categories of clinical research
• SOPs on:
- Interaction with the competent authorities
- Archiving
- Insurance
- Management of IMP
- Collection, circulation and storage of blood and tissue
samples (in collaboration with the EU biobanks infrastructure,
BBMRI).
Working party 3 on Vigilance
Chair Nicola Fabris
• National differences in the adverse event reporting
system for clinical trials on medicinal products and
for other categories of clinical research
• Both pre-registration trials and post-marketing
studies
• SOP on adverse event reporting under these various
conditions
Working party 4 on Data Management
Chair Christian Ohmann
• Survey on existing resources for data management
in the public research centres within the network
• Documents defining specifications for ECRIN data
centres providing high-quality data management for
multinational studies
Working party 5 on Monitoring
Chair Geneviève Chêne
• Risk assessment tool for multinational clinical
studies
• SOPs on:
- Risk assessment
- Study monitoring
Working party 6 on Quality Assurance
Chair Jacques Demotes
• SOP on:
- Development, approval, review of SOPs and SOP
management to be used by the other WPs
- Responsibilities within ECRIN and on task
delegation contracts between sponsors and ECRIN
in the support to multinational clinical research
projects
• Reviews the SOP drafts produced by the other WPs,
ensuring both consistency and comprehensiveness
of the set of SOPs
Working party 8 on Education
Chair Pierre Lafolie
Teaching programme on the conduct of multinational
clinical research for the ECRIN staff, targeting first
the European correspondents through a train-thetrainer session during the summer school, then the
staff of the national networks
PPI 2008-2011
• FP7
• Implementation of tools developed during TWG
• ECRIN network will change into a sustainable
European institution, with a legal status of panEuropean infrastructure.
PPI – Organisation
WP1 Management
WP2 Legal status and Governance
WP3 Financial plan
WP4 GMP facilities for Biotherapy
WP5 Education and Training
WP6 Extension of ECRIN
WP7 Capacity building
WP8 Quality Assurance
WP9 Communication
WP10 Data Centres
WP11 Pilot project