ECRIN General PresentationSupporting Clinical Trials Across Borders

Gonzalo Calvo| 26-01-16

ECRINOverview

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)

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2004: 1st project (European Union Framework Program 6, FP6) on strategy development involving six countries

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

2008: 3rd project (FP7) on infrastructure business plan and legal status with 14 countries

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

Dates: 2012-2017

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

History: Key Dates

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Why ECRIN?

Context

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

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ECRIN-ERIC statutesSustainable support through Member country contribution

Core Team, EuCos, National Partners

Organisation: Distributed Infrastructure

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

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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: 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)

ECRIN CountriesMembers, Observers and New Applicants

Countries applying to ECRINParticipants in ECRIN-IA (in addition to dark blue)ECRIN Member and Observer Countries 8

About ECRIN

How ECRIN Supports Trials

Agenda

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Support During Preparation, Validation and Implementation

Overview

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

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Coordinated Services for Multinational Trial Management

A Closer Look at ECRIN Services

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Coordinating countriesECRIN-ERIC countriesNon-ECRIN-ERIC countries

Activity OverviewECRIN Is Involved in Advice, Consultancy and Management Services for 30+ Trials, with an Average of 7 Countries per Trial

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ECRIN trial portfolio

Support During PreparationECRIN-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

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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

Support During ImplementationECRIN Provides Tools to Address Regulatory & Ethical Issues

campus.ecrin.org

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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

Support During ImplementationECRIN Provides Tools to Measure Outcome & Assess Risk

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

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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

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Thank you!

Any questions?