Gonzalo CalvoGonzalo.calvo@clinic.ub.es

SCReN

Created by the Instituto de Salud Carlos III (National Institute of Health) thorough a nacional public call

When?: January 2014

What?: Decentralize (Transversal) Network (No legal

personality)

Where?: 11 regions

Who?: 29 Clinical trial units, with 86 professionals(contracted with the funds) & the active collaboration of more than 210 specialists.

SCReN: Decentralized Network Structure

SCReNNOT LEGAL ENTITY

UICEC

UICEC

UICEC UICEC

UICEC UICEC

UICEC UICEC

UICEC 2

UICEC 4

UICEC 5

UICEC 3

UICEC 1

UICEC 6

UICEC 7

UICEC 1

UICEC 2

UICEC 3

UICEC 4

29 UICECPFV

PMBGD

PRM

Executive Committee

Profiles

16

33

46

56 60

1

5 69 8

0

5

9,511,5

10

02 2

46

0

10

20

30

40

50

60

70

Contratación por Programas

PRM

PFV

PGDE

PCyF

Innovation in Investigators Initiated Clinical Trials

ScientificHigh

Quality Ideas

INVESTIGATOR LEADERSHIP

Best PracticesSite

collaboration

Flexible Structure

Risk adaptation

Education

NETWORK Def: An association of individuals having a common interest, formed

to provide mutual assistance, helpful information.

CTUs “more experienced”

CTUs “less experienced”

Sr. PM Jr. PM

SCReN in Numbers

PatientsMore than 7.000

UICECS29Years3

Contracts110

Clinical Trials60

Enrolment sites636

Project Selection Process

Principal Investigator Initial Proposal

CTU: SupportMethodological supportManagement feed back

Budget calculation

Final Proposal Ready for Evaluation

Validation(Programs)

Evaluation1 member executive committee

2 evaluators (CTU proposals)

AcceptanceQuestions & Answers

Decline

Evaluators:

A SCReN decision

Evaluator panel: Representing proposed by every Clinical Trial

Unit

Main Criteria:

• Methodology

• Feasibility

• Collaboration

2 evaluators per project+

member of the executive committee

Evaluation Milestones

2014

2015

2016

60 days

10 days

10 days

4 months

1 month

3 Weeks

Validation Evaluation

Project Incorporation

19

12

1514

Studies: Long commitment

ECRIN General Presentation

Supporting Clinical Trials Across Borders

First and last name| Date

About ECRIN

Overview of ECRIN Activities

Role of European Correspondents (EuCos)

Agenda

ECRIN

Overview

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)

15

Why ECRIN?

Context

Need for multinational trials

Greater access to patients, medical expertise and appropriate facilities Higher methodological standards Shared costs, tools and procedures Potential for broad implementation of research outcomes Avoidance of duplication of trials

But several obstacles to multinational 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

16

Values and Approach

17

We collaborate with diverse partners in Europe and beyond to address the key bottlenecks to multinational clinical trials

We fill a gap in the European clinical research landscape

Through our collaborative approach, we aim to support trials that have the greatest public health impact

We can work across a wide range of clinical trial areas (e.g., medicines, medical devices, nutrition, surgical procedures)

We respect the highest ethical and methodological standards

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 ECRINHost 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 Countries

Members, Observers and New Applicants

ECRIN Member Countries

ECRIN Observer Countries

Applicants

21

Additional Partners

22

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

About ECRIN

Overview of ECRIN Activities

Role of European Correspondents (EuCos)

Agenda

23

Overview

24

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

25

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

26

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

27

Quality Assurance & Data Centre Certification

28

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

Capacity Building Projects

29

ECRIN participates in capacity building projects to enhance multinational clinical research

Diverse in scope and stakeholders (Europe/international)

Current projects aim, for example, to establish shared services in biomedical areas, further develop infrastructure, and foster international cooperation in non-commercial trials

Outcomes benefit ECRIN-supported trials

Laying the Foundation for Improved Multinational Clinical Research

About ECRIN

Overview of ECRIN Activities

Role of European Correspondents (EuCos)

Agenda

30

A Closer Look at the EuCos: Overview of Role

31

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

Support During Preparation

Role in Managing the Trial Portfolio (1/3)

32

Support investigators to prepare applications for

multinational funding: logistical and operational

components

Provide guidance on the services required for a trial,

and logistical and operational aspects: regulatory and

ethical issues, insurance, contracting, trial

monitoring, costs

Support During Validation

Role in Managing the Trial Portfolio (2/3)

33

Provide assistance on applications for ECRIN scientific

and methodological evaluations

Coordinate logistical assessments:

Assess the availability/feasibility of services

Identify CTUs

Lead cost calculation for defined services

Support During Implementation

34

Organise communication between the sponsor, ECRIN and CTUs

Coordinate the implementation and follow-up of services:

Manage contractual aspects (between sponsor, ECRIN Core Team, CTUs)

Coordinate the initiation of services by CTUs and follow up on service provision (according to trial tasks, timelines and procedures)

Provide assistance if issues arise between the sponsor and CTUs

If requested, provide operational trial management

Role in Managing the Trial Portfolio (3/3)

ECRIN experience in trial support

Since 2009

As of 2017, 40 European-funded trials

In 2016, 11 new trials funded

6 clinical trials (out of 16)

1 clinical trial

4 clinical trials

H2020 EXPERIENCE IN SPAIN

COORDINADOS

-LIVERHOPE

-ORTHOUNION

-HIVACAR

PARTICIPANTES-RESPINE (FR)-PROOF (DE)

Challenges

• Business Continuity . . .

• Project Funds Managment. . .

• UICECs selection

• Low enrolment rates . . .

• Lack of “Legal entity”. . .

• Salaries

Gracias