ECRIN General Presentation

Transcription

1 ECRIN General Presentation Supporting Clinical Trials Across Borders Gonzalo Calvo

2 ECRIN Overview A non-profit organisation with the legal status of European Research Infrastructure Consortium (ERIC) Mission: support the conduct of independent, multinational clinical trials across Europe Diverse support areas: funding applications, protocol evaluation, trial management, quality assurance, etc. 8 Member & Observer Countries: Czech Republic, France, Germany, Hungary, Italy, Portugal, Spain, Switzerland (additional countries about to join) 2

3 History: Key Dates 2004: 1 st project (European Union Framework Program 6, FP6) on strategy development involving six countries 2006: 2 nd project (FP6) on tools development with 12 countries; listing on European Strategy Forum on Research Infrastructures (ESFRI) roadmap 2008: 3 rd project (FP7) on infrastructure business plan and legal status with 14 countries 2012: 4 th project (FP7), ECRIN Integrating Activity (ECRIN-IA) with 23 countries Dates: Aims: structure national scientific partners and develop capacity to manage multinational trials, strengthen user communities, develop databases and toolkits, foster patient communication, conduct pilot multinational trials 2013: Awarded ERIC status 3

4 Context Why ECRIN? Need for international trials Greater access to patients and medical expertise Higher methodological standards Shared costs, tools and procedures Potential for broad implementation of research outcomes Avoidance of duplication of trials But several obstacles to international trials Infrastructure interoperability, regulation, ethical review, insurance, contracts, management, cost models, funding, languages, etc. ECRIN as a solution Provides support to sponsors in investigator-initiated trials A pathway through Europe s fragmented health and legal systems 4

5 ECRIN-ERIC statutes Sustainable support through Member country contribution 5 5

6 Organisation: Distributed Infrastructure Core Team, EuCos, National Partners ECRIN Core team based in Paris Develops common tools and procedures, manages trial portfolio and EuCos European Correspondents (EuCos) Point of contact between Core Team and national partners National scientific partners Network of clinical trial units (CTUs) able to manage trials in-country Framework contracts with ECRIN Linked third parties in Horizon2020 Provide services to ECRIN at non-profit costs Host EuCos 6

7 Organisation National Scientific Partners Czech Republic: CZECRIN Czech Clinical Research Infrastructure Network France: F-CRIN French Clinical Research Infrastructure Network Germany: KKSN Netzwerk der Koordinierungszentren für Klinische Studien Hungary: HECRIN Hungarian Clinical Research Infrastructure Network Italy: Istituto Superiore di Sanita (ISS), Rome Portugal: PtCRIN Portuguese Clinical Research Infrastructure Network Spain: SCReN Spanish Clinical Research Network Switzerland: Swiss Clinical Trial Organisation (SCTO)

8 ECRIN Countries Members, Observers and New Applicants Countries applying to ECRIN Participants in ECRIN-IA (in addition to dark blue) ECRIN Member and Observer Countries 8

9 Agenda About ECRIN How ECRIN Supports Trials 9

10 Overview Support During Preparation, Validation and Implementation Guidance, consulting and operations management for trials including: Ethical and regulatory submission Trial monitoring Adverse event reporting Data management Support for funding applications through ECRIN-On-Board (methodology / protocol review; input on logistical, operational / structural components) Provision and maintenance of tools for trial regulation, ethical requirements, outcome measures, risk-adapted monitoring, etc. Interaction with disease-related investigation networks 10

11 A Closer Look at ECRIN Services Coordinated Services for Multinational Trial Management 11

12 Activity Overview ECRIN Is Involved in Advice, Consultancy and Management Services for 30+ Trials, with an Average of 7 Countries per Trial Coordinating countries ECRIN-ERIC countries Non-ECRIN-ERIC countries 12

13 ECRIN trial portfolio

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15 Support During Preparation ECRIN-On-Board Initiative for Funding Applications ECRIN-On-Board offers support to multinational, clinical research projects preparing applications for multinational funding (e.g., Horizon 2020, E-Rare). Support areas: Consulting on methodology and protocol review Consulting on logistical and operational aspects, focusing on: regulatory and ethical aspects, insurance, contracting, monitoring, costs, risk and mitigation, trial oversight, site identification and selection Advice on structural components: work package architecture, impact, management, governance and consortium Note: ECRIN does not draft the actual application For information on eligibility and how to apply to calls (H2020 and others, e.g. E- Rare), see ecrin.org/en/support-clinical-trials/support-for-funding-applications 15

16 Support During Implementation ECRIN Provides Tools to Address Regulatory & Ethical Issues Ex. 1: ECRIN Campus for Regulatory & Ethical Requirements Central resource covering 22+ European countries and multiple study types. Use to: Locate country-specific competent authorities and ethics committees Consult summary of requirements in each country Browse related documents campus.ecrin.org 16

17 Support During Implementation ECRIN Provides Tools to Measure Outcome & Assess Risk Ex. 2: Medical Device Outcome Measure Database Allows you to identify relevant outcomes related to specific medical devices. Information on: Product names Risk class Disease Body system Intervention type and device category Source publication Ex. 3: Risk-Based Monitoring Toolbox Enables researchers to create appropriate risk-based strategies Choose risk assessment, monitoring adaptation, or study conduct tools to find related tool names, institutions where they are used, links, and feedback 17

18 Conclusion: Why Work With ECRIN? Bringing Together European Medical Research Communities for More Robust Trials Access to expertise and facilities at not-for-profit cost Scientific excellence and medical expertise Protocol review by ECRIN Scientific Board Multinational collaboration with scientific communities Access to trial participants, ensuring robustness of results Possibility to have ECRIN Data Centre Certification, leading to an independent certificate of quality after a successful audit Access to ECRIN-On-Board in the application phase, increasing chances of proposal acceptance Access to tools throughout project implementation 18

19 Thank you! Any questions?