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ECRIN-PPI ecrin

ECRIN-PPI www.ecrin.org. Finland FinnCRIN. Sweden SweCRIN. Denmark DCRIN. Ireland ICRIN. UK UKCRN. EORTC. Germany KKS. EFGCP. Austria ATCRIN. France Inserm. Hungary HECRIN. Switzerland SCRN. Spain SCReN. Italy IRFMN & CIRM.

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ECRIN-PPI ecrin

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  1. ECRIN-PPI www.ecrin.org www.ecrin.org

  2. Finland FinnCRIN Sweden SweCRIN Denmark DCRIN Ireland ICRIN UK UKCRN EORTC Germany KKS EFGCP Austria ATCRIN France Inserm Hungary HECRIN Switzerland SCRN Spain SCReN Italy IRFMN & CIRM National networks of Clinical Research Centres / Clinical Trial Units www.ecrin.org

  3. ECRIN objectives • Integration of EU clinical research capacity • support to investigators • support to sponsors in multinational studies -> unlocking latent potential : scientific, patients • Integration of public funding -> avoiding duplication of studies & wasting of money • Harmonisation of tools, training and practice • Improved quality, credibility, transparency • ----> harmonisation of legislative systems ? www.ecrin.org

  4. Which clinical research projects ? • Any type of clinical research • Clinical trials on health products, biotherapy • Surgery, radiotherapy, multimodal trials • Diagnostic, imaging, biomarker, genetic studies • Physiology, physiopathology, epidemiology • Any medical field • Special focus on rare diseases / orphan drugs • Any sponsor : public institution, public-private partnership, biotechnology & medical device SMEs, pharmaceutical industry • -> support to investigators • -> support to sponsors in multinational studies www.ecrin.org

  5. ECRIN, an integrated infrastructure for clinical trials in the EU • ECRIN-1 (2004-2005) : Identifying bottlenecks • ECRIN-2 (2006-2008) : Design of the infrastructure • ECRIN-3 (2008 -> ) : ESFRI roadmap Preparation, construction and operation of the infrastructure supporting multinational clinical trials in the EU • In line with expectations of FP7 ‘Innovative Medicines Initiative’ www.ecrin.org

  6. ECRIN-1 (2004-2005) : identifying bottlenecks ECRIN-RKP (FP6-funded): -> survey and comparative analysis on 1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, 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 -> reports on www.ecrin.org www.ecrin.org

  7. ECRIN-2 (2006-2008) :designing the infrastructure ECRIN TWG (FP6-funded) TRANSNATIONAL WORKING GROUPS : -> Guidelines and procedures 1 - ethics 2 - regulation 3 - adverse event reporting 4 - data management 5 - monitoring 6 - quality assurance – SOPs 7 - education www.ecrin.org

  8. Which category of research ? Survey on categories of research • 1 – CT on medicinal products • 2 – CT on medical devices • 3 – Other therapeutic trials • 4 – Diagnostic studies • 5 – Nutrition studies • 6 – Other clinical research • 7 – Epidemiology www.ecrin.org

  9. Comparison of national requirements EC CA sponsor insurance AER www.ecrin.org

  10. The definitions allow to determine which is the relevant category of research (WP6, English) The checklists summarise the requirements for multinational support to sponsors and investigators, stratified by category of research (WP6, English) The procedures, stratified by task, provide detailed description of the specific requirements for each category of research. They are based on a core element valid throughout the EU, with adaptation to the particularities of each country (each WP, English) National laws and regulations All documents are based on the national laws and regulations (national language), and updated. www.ecrin.org

  11. ECRIN-3 (2008-) : Integrated services to multinational studies • Flexible, integrated services (one-stop shop) in the conduct of the study 1 - interaction with ethics commitees 2 - interaction with competent authorities, regulatory affairs 3 - drug dispensing 4 - adverse event reporting 5 - data management – data centres 6 - study monitoring 7 - circulation and storage of blood and tissue samples 8 - GMP manufacturing of biotherapy products 9 - patients recruitment and investigation www.ecrin.org

  12. ECRIN-3 (2008-) : Integrated services to multinational studies (2) • Information and consulting during the preparation of the study 1 - Methodology, protocol review and adaptation of study protocol to transnational constraints 2 - Ethical review 3 - Meta-analysis 4 - Centre selection, stimulation of patients’ enrolment 5 - Cost evaluation 6 - Funding opportunities 7 - Biostatistics 8 - Data safety and monitoring committees 9 - Insurance www.ecrin.org

  13. CRC GMP CRC CRC CRC DC NNC CRC CRC NNC EC NNC EC EC CRC DC ECRIN GMP EC NNC EC NNC EC CRC CRC NNC CRC CRC GMP CRC CRC CRC CRC= Clinical research centre DC= Data centre EC= European Correspondent GMP= GMP facility for biotherapy NNC= National Network Coordination www.ecrin.org

  14. ECRIN - PPI : preparation phaseWorkpackages • 1 - Management • 2 - Legal status and governance • EU legal status (Art 171 ?) allowing staff recruitment, circulation of money, contracts with sponsors, application to calls • framework contracts, management of IP • Governance • Coordination, network committee, advisory board, working parties, EU correspondents PLUS : • Project development board : financial plan • Scientific board and rules of access • Joint strategic board (with biobanks – EATRIS) www.ecrin.org

  15. ECRIN - PPI : preparation phaseWorkpackages • 3 - Financial plan -> business plan, mechanism for long-term financial sustainability • Survey on costs of services (to investigators, to sponsors) • Survey on national funding to the infrastructure • Survey on public and PPP funding to projects • -> ERA NET ? • Cost of construction • Capacity building • GMP facilities • Datacenters • Cost of operation • National and EU components, including management and QA www.ecrin.org

  16. ECRIN - PPI : preparation phaseWorkpackages • 4 - GMP facilities for biotherapy / biopharmaceuticals • Survey on existing resources and needs • Cost evaluation, implementation plan • 5 - Education and training • training for staff, e-tool • 6 – Extension • New MS (NL, Be, Ice, Tur, Pt, Ser, Pl, etc…) • New infrastructures (pediatrics ?) • 7 - Capacity building - relay to sponsors tasks • Allow national coordinations to relay sponsors’ tasks www.ecrin.org

  17. ECRIN / ESFRI : preparation phaseWorkpackages • 8 - Update and upgrade of the QA system • Update of multinational SOPs and guidelines (change in national and EU regulation, new members) • WP1 Ethics • WP2 Regulation • WP3 Vigilance • WP5 Monitoring • Upgrade of national QA system • Coordination with EATRIS, Biobanks • 9 – Communication • With users, with patients, with citizens • 10 – Datacentres • Specification for accreditation of datacentres, cost evaluation • Accreditation of a prototype • 11 - Pilot projects www.ecrin.org

  18. EATRIS BBMRI National networks, national project coordinators, European correspondents Joint strategic board Ministries agencies Network Committee Advisory board Scientific board Project development board www.ecrin.org

  19. ECRIN / ESFRI : after the preparation phase • 1 – Operation phase • Progressive development of services to investigators and sponsors -> Sustainability : self-financing / operation revenues (public, industry, PPP), open I3 calls, national support • 2 – Construction phase • Capacity building: public institutions acting as sponsors • GMP facilities for biotherapy • Datacentres -> National funding, loan to EIB (RSFF), structural funds, limited funding from the Capacity programme www.ecrin.org

  20. Synergies with other ESFRI Infrastructures biobanking model validation samples data targets biomarkers samples data biomarkers targets Biobanks Biomolecular Resources Clinical Trials Biotherapy Structural Biology EATRIS INFRAFRONTIER Bioinformatics Phase III Target Id Target Val Hit Lead Lead Optim Preclin Phase I Phase II Research Discovery Development www.ecrin.org

  21. Synergy ECRIN – EATRIS www.ecrin.org

  22. Synergy / ECRIN – EATRIS - Biobanks • ECRIN will support EATRIS projects reaching the clinical step : EATRIS / phase 1, ECRIN / phase 2 and full development • GMP manufacturing facilities for clinical batches : • ECRIN -> generic centres and centres for biotherapy / cell therapy • EATRIS -> disease-oriented biopahramaceuticals (recombinant proteins, monoclonals, oligonucleotides, vaccines…) • Joint working groups EATRIS – Biobanks - ECRIN • databases - knowledge management • regulation - legislation • SOPs • Public-private partnership through IMI www.ecrin.org

  23. Discoveryresearch Preclinicaldevelop. Translationalmedicine Clinical develop. Pharmaco- vigilance Risk assessmentwith regulatory authorities Predictive pharmacology Bottlenecks identified in the Innovative Medicines Initiative (IMI) Strategic Research Agenda Knowledge Management Education & Training Predictive toxicology Identification of biomarkers Patient recruitment Validation of biomarkers Efficacy Safety www.ecrin.org

  24. Synergy / ECRIN – IMI • IMI as an user : implementation of efficacy and safety PPP precompetitive IMI projects requires an infrastructure for clinical trials in the EU, particularly to address • the definition and validation of biomarkers • patients recruitment • post-marketing safety studies • IMI as a partner (with other ESFRI-BMS infrastructures) • IMI knowledge management : integrated, interoperable and multidisciplinary databases • IMI education and training : multidisciplinary / multinational profiles, mobility academia – industry. www.ecrin.org

  25. EU-wide disease-oriented networks EU-wide infrastructures networks Clinical (ECRIN) Preclinical Drug discovery cancer brain diabetes inflammation infection Infrastructures for multinational clinical research : clinical research centres, cohorts, biobanks, databanks, imaging Infrastructures for preclinical R&D: toxicology models and databases, biopharmaceutical manufacturing facilities Infrastructures for drug discovery: high throughput ‘omic’ facilities, in silico and animal models Research networks Investigators networks Patients’ registries FP7 IMI : Europe-wide infrastructures and disease-oriented networks www.ecrin.org

  26. ECRIN – PPI: advisory board - European stakeholders and regulators 1 - EU Commission, also representing ‘Innovative Medicines Initiative’ (IMI) 2 - European Medicines Agency (EMEA) 3 - Clinical Trials Facilitation Team (competent authorities from the 27 EU MS). - Users and partners Industry: 4 – EFPIA, also representing IMI 5 – EuropaBio (representing the biotechnology SME sector) Public sponsors and scientific agencies: 6 - European Science Foundation (ESF) 7 - Europe & Developing Countries Clinical Trials Programme (EDCTP) Scientific associations and networks (users): 8 – disease-oriented learned society (on a rotational basis) 9 – disease-oriented learned society (on a rotational basis) Patients’ associations: 10 - European AIDS Treatment Group (EATG) 11 - European Association for Rare Diseases (EURORDIS) Partner in communication: 12 - Orphanet www.ecrin.org

  27. ECRIN – PPI: scientific board • Projects will be evaluated, selected and followed by the Scientific Board, composed of • representatives of the national infrastructures, • of scientific experts in the field, • of methodologists and biostatisticians, • of members of the working parties on ethics, regulation, vigilance, and monitoring, • and of representatives of patients associations. • Distinct from Network Committee, but at least one common member • -> nomination of • members of the ECRIN Scientific Board, • and of its Chair www.ecrin.org

  28. ECRIN – PPI: contract negotiation • Management structure • Annex I • A forms • Budget • Consortium agreement • Communication plan www.ecrin.org

  29. ECRIN – PPI: contract negotiation • Evaluation : reduction in WP11 on Pilot projects • Funding : 6.428 -> 5.8M€ (-10%) • Cut in WP11 budget - Reduction in manpower 184 -> 78 person-month - Operating budget almost unaltered (scientific board) 50.000€ -> 36.983€ www.ecrin.org

  30. ECRIN – PPI: Related EU projects • Structuring projects • ICREL : EU Directive • Videoconferencing system • Connecting disease-oriented network (bipolar disorder) • Other ? • Possible pilot projects • Transvac • Polypill • BENEDIC • Other ? • Possible funding mechanisms : • EU funding (Health priority, IMI, Infrastructure I3) • coordination of national funding (ERA-net) www.ecrin.org

  31. ECRIN – PPI: Impact on EU legislation • Written suggestions for the EC-EMEA conference on the revision of the clinical trials Directive • Lobbying • National • Commission • EU Parliament www.ecrin.org

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