ECRIN General PresentationSupporting Clinical Trials Across Borders

Amélie Michon| 06/03/2018

About ECRIN

Overview of ECRIN Activities

Participation in clinical research projects

Agenda

ECRINOverview

§ A non-profit organisation with the legal status of European Research Infrastructure Consortium (ERIC)

§ Mission: support the conduct of multinational clinical trials across Europe

§ Diverse support areas: trial management, preparation, protocol evaluation, quality assurance, etc.

§ 9 Member and Observer Countries: Czech Republic, France, Germany, Hungary, Italy, Norway, Portugal, Spain, Switzerland (additional countries about to join)

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History At A Glance

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§ 2004: ECRIN created; began 1st project (EU Framework Program 6, FP6) on strategy development involving six countries

§ 2006: 2nd project (FP6) on tools development with 12 countries; listed on European Strategy Forum on Research Infrastructures (ESFRI) roadmap

§ 2008: 3rd project (FP7) with 14 countries to develop ECRIN’s business plan and legal status

§ 2012: 4th project (FP7), ECRIN Integrating Activity (ECRIN-IA), with 23

countries to structure national scientific partners and build their capacity to manage multinational trials

§ 2013: Awarded ERIC status

§ 2016: Listed as an “ESFRI Landmark” on the updated ESFRI Roadmap

EuCos, Core Team, National Partners

Organisation: Distributed Infrastructure

§ European Correspondents (EuCos)§ Implement work in-country in

coordination with national partners

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§ Core Team§Develops ECRIN’s strategy, common

tools and procedures § Supports EuCos

§ National Partners (networks of clinical trial units, CTUs)§Manage trials in-country and provide services to ECRIN§Host EuCos

National Scientific Partners

Organisation

§ 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: ISS (Istituto Superiore di Sanità) / ItaCRIN§ Norway: NorCRIN (Norwegian Clinical Research Infrastructure)§ Portugal: PtCRIN (Portuguese Clinical Research Infrastructure Network)§ Spain: SCReN (Spanish Clinical Research Network)§ Switzerland: SCTO (Swiss Clinical Trial Organisation)

ECRIN CountriesMembers, Observers and New Applicants

ECRIN Member CountriesECRIN Observer CountriesApplicants

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Additional Partners

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§ Affiliate/international partners include:§ Therapeutic Innovation Australia Ltd (TIA)§ Korea National Enterprise for Clinical Trials (KoNECT)§ European Vision Institute Clinical Research Network

(EVICR.net) (Portugal)§ National Center for Advancing Translational Sciences

(NCATS) at the National Institutes of Health (NIH) (USA)§ Oswaldo Cruz Foundation (FIOCRUZ) (Brazil)§ Foundation for Biomedical Research and Innovation

(FBRI) (Japan)

Collaborating Across Borders for Greater Impact

§ Collaboration with specialised centres and disease-networks in Europe and worldwide

A Closer Look at the EuCos: Overview of Role

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§ Act as the link between the Core Team, other EuCos, national scientific partners, and trial stakeholders

§ Manage the ECRIN trial portfolio in-country, providing support during trial preparation, validation and/or implementation

§ Act as “Coordinating EuCo” (typically when trial sponsor is in their country) or “Participating EuCo” in multinational trials

Amelie MICHON amelie.michon@ecrin.orgLuc Wasungu luc.wasungu@ecrin.org

About ECRIN

Overview of ECRIN Activities

Participation in clinical research projects

Agenda

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Overview

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§ Support for multinational trial preparation, protocol review and management

§ Development of tools

§ Quality assurance and data centre certification

§ Participation in capacity building projects

Diverse Activities to Facilitate Multinational Clinical Research

Coordinated Support from Preparation to Implementation

Main Activity: Trial Support

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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

Tools to Facilitate Multinational Trials (1/2)ECRIN Provides Tools to Address Regulatory & Ethical Issues

campus.ecrin.org

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Medical Device Outcome Measure Database§ Identifies relevant outcomes

for specific medical devices. Information on:§ Product names§ Risk class§ Disease§ Body system§ Intervention type, device category§ Source publication

Tools to Facilitate Multinational Trials (2/2)ECRIN Provides Tools to Measure Outcome & Assess Risk

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

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Quality Assurance & Data Centre Certification

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§ ECRIN has an internal quality management system

§ Promotes quality externally through, for example, the Data Centre Certification programme:§ Identifies non-commercial CTUs in Europe that can provide

safe, secure, compliant and efficient management of clinical research data

§ CTUs are tested for compliance with ECRIN data standards through on-site audits by an independent Certification Board

Promoting Quality Inside and Outside the Organisation

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§ ECRIN-IA

§ CORBEL MiRoR§ RI-Train § PedCRIN§ EPTRI TESA II§ TRANSVAC § RISCAPE CRIGH§ EOSC Pilot Aim: to establish shared services in biomedical areas, further develop infrastructure, and foster international cooperation in non-commercial trials

Participation in Capacity building projectsLaying the Foundation for Improved Multinational Clinical Research

About ECRIN

Overview of ECRIN Activities

Participation in clinical research projects

Agenda

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Coordinating countries

Participating countries

Activity OverviewECRIN Is Involved in Advice, Consultancy and Management Services for 40+ Trials (current and past)

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§ 19 clinical trials / 1 clinical trial

§ Main tasks: Provision of coordinated services to support the implementation and the management of multinational clinicaltrials:§ coordination of reg. and ethical submissions,§ monitoring, § Local project management§ data management, …

Participation in Clinical Research projects24 clinical trials with EU fundings 2014 - 2017

Trial Portfolio in France

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ECRIN involvement (all sources of fundings)

§ 16 Projects (French coordination)§ 11 in preparation or active projects: 7 in collaboration with CHUs with

AP-HP (H2020: R-Link, EU-TRAIN), CHU Toulouse (PedCRIN funding:

OTBB3), CHRU Lille (H2020: FAIR-PARK), CHU Montpellier (H2020:

ADIPOA-2, RESPINE) and CHU Nice (TERIS)

§ 5 closed projects

§ 16 projects (Coordination outside France)§ 13 active projects: includes collaboration with CHUs as ECRIN national

partners for France: CHU Nantes, CHRU Lille, HCL, CHU Nice, AP-HP

(PARTNERS F-CRIN platform), CHU Bordeaux (EUCLID F-CRIN platform)

§ 3 closed projects

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France as Coordinating country

Ex 1: FAIR-PARK II

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§ H2020 PHC-13-2014: Clinical research on chronic disease

§ Coordinated by Pr David DEVOS, CHRU Lille (France)

§ Involvement of NS-PARK in coordination of the French sites and F-CRIN coordination in the supervision of WP3 (recruitment)

§ ECRIN as a beneficiary of the European project involved in WP2 (RCT)

§ 1 multinational trial running in 8 countries (FR, CZ, DE, NL, UK, ES, PT, AT)

§ Initiated in January 2015

ECRIN Support for funding application

Ex 1: FAIR-PARK II

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Dec. 2013 : Launch of the call

May 2014

Jan. 2015 : Project funded!

Mar. 2014 : 1st step

Aug. 2014 : 2nd step (full proposal)

- Regular TCs with sponsor, Coordinator and all partners- Detailed discussion with the sponsor on ECRIN tasks in the clinical trial (task delegation), advices on regulatory and ethical aspects, insurance, contracting, trial monitoring- Involvement in the writing of WPs and Ethic section- Budget preparation - Review of the full proposal

- Involvement in TCs with Partners,- 1st Discussion with sponsor to define ECRIN tasks- Review of the letter of Intent

ECRIN Support for the conduct of the project

Ex 1: FAIR-PARK II

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§ Involvement in WP2-Set-up of the RCT Logistic, monitoring and QA

§ Provision of operational services to support CHRUL in performing the trial in Germany, United Kingdom, Austria, The Netherlands, Spain, Portugal and Czech Republic:§ Regulatory and ethical approval and follow-up § Monitoring of the clinical trial § Local pharmacovigilance

§ Coordination of the provision of the services in 7 countries: § Implementation and follow up according to the tasks, the timelines, the

budget and the procedures of the trial§ Main contact point for the sponsor§ Assistance if issues arise between the sponsor and CTUs

Partenaires nationaux ECRIN

EuCo

France as Participating country

Ex 2: BETA 3 - LVH

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§ H2020 PHC-13-2014: Clinical research on chronic disease

§ Coordinated by Pr Jean-Luc Balligand, UC Louvain (Belgium)

§ ECRIN as a beneficiary of the European project

§ 1 multinational trial running in 6 countries (BE, DE, PT, FR, PO, IT, AT)

§ Initiated in January 2015

§ CHU Nantes: ECRIN national partner in France and in charge of Reg. and ethical submission, monitoring and local PV on behalf of ECRIN and the sponsor in France

Closer Look at H2020

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ECRIN Involvement

Thank you!

Any questions?