Franco-British bilateral symposium

Clinical research: what can we learn from each other ?

The Royal Society, London

16-17 October 2012

European Clinical Research Infrastructure

Network (ECRIN)

Jacques Demotes jacques.demotes@inserm.fr

www.ecrin.org

Obstacles to international

cooperation in clinical trials

Legislation / regulation / oversight

– insufficient harmonisation

– no risk adaptation

Fragmentation of funding

Infrastructures

– interoperability

– insufficient development

Differences in health systems

Education

Culture, ethics

Transparency

Patients and citizens awareness

Language

Make Europe a single area for

clinical research

Pan-European, distributed

infrastructure providing coordinated

services to multinational clinical

research in Europe:

- access to patients and to expertise

throughout Europe

- despite the fragmentation of

health, legislative and funding systems

- support to investigators and sponsors

in multinational studies

A pan-European

infrastructure for

clinical research in

any disease area

BBMRI - Biobanks

EATRIS - Translational research facilities

ECRIN - Clinical trial platform

ELIXIR – Data repositories

Infrafrontier - Mouse archives and clinics

INSTRUCT - Structural biology facilities

EMBRC - Marine biology resources

ERINHA - High-security labs

EuroBioImaging – Imaging facilities

EU-Openscreen - Chemical libraries

ANAE - Analysis and experimentation on ecosystems

ISBE – Infrastructure for systems biology

MIRRI – Microbial resources

ESFRI - Biological and Medical Sciences

2006

2008

2010

Barre des Ecrins French Alps alt. 4102 m

ECRIN-RKP

ECRIN-ERIC

OPERATIONS

ECRIN-IA

STRUCTURING

ECRIN-PPI

ECRIN-TWG

List of Chapels

The chapel of the Langue of Castille, Leon and

Portugal

The chapel of the Langue of Provence

The chapel of the Langue of Aragon

The chapel of the Langue of Auvergne

The chapel of Our Lady of Philermos

The chapel of the Langue of Italy

The chapel of the Langue of Germany

The chapel of the Langue of France

The chapel of the Anglo-Bavarian Langue

St John’s Co-Cathedral, Malta

Spain

CAIBER

France

F-CRIN

Germany

KKSN

UK

CTU Leeds

Ireland

ICRIN

EORTC

Italy

ISS

Switzerland

SCTO

Austria

ATCRIN

Hungary

HECRIN

Sweden

SweCRIN

Finland

Finn-Medi

Denmark

DCRIN

Poland

POLCRIN

1 - Operations: ECRIN-ERIC

Services to multinational clinical trials

Pending acceptance by the Scientific

Board

How does ECRIN support

multinational trials ?

Information and consultancy during the preparation of the trial

Information on regulatory and ethical requirements

Information on sites and participant recruitment

Information on clinical trials units

Information on insurance

Information on cost and funding opportunities

Information on contracting

Adaptation to local context

Services during the conduct of the trial

• Interaction with competent authorities and ethics committees

• Support with insurance contracting

• Adverse event reporting

• Monitoring

• Data management

• Investigational medicinal product management

• etc.

Full protocol

Scientific evaluation

Logistical assessment

Contract with sponsor

How does ECRIN coordinate its

national partners ?

ECRIN ERIC

Scientific Partners

(national networks & hubs)

Framework contracts on

Provision and costs of services

Quality assurance

coordinated support and

services to multinational trials

single contract

PIC number and third parties

Natl

hub

Natl

hub

Natl

hub

Natl

hub

Natl

hub

Natl

hub

Natl

hub

Natl

hub

EC

EC

EC

EC

EC

EC

EC

EC

ECRIN

Core

Team

CRC

2 - Structuring activities

ECRIN-Integrating Activity

ECRIN data centres:

certification process

First call issued on

1st June 2011

www.ecrin.org

ECRIN-IA (2012-16):

structuring pan-European

investigation networks

ECRIN-IA structuring of

disease-oriented networks

Mapping of research capacity

– Clinical investigation (conduct of trials)

– Translational research centres (‘users’)

Establishment of a pan-European network and hub

Specific regulatory and ethical requirements

Development of common standards for quality assurance

and monitoring

Standardisation of investigation procedures

Registry of outcome measures

Methodology taskforce

Specifications for a data management tools (trials, cohorts)

Transposition into a training module

Capacity building and network

expansion policy in ECRIN-IA

France

F-CRIN

Denmark

RH

Germany

KKSN

Finland

FINNMEDI

Ireland

MMI

EORTC

Poland

MUW POlAND

Spain

CAIBERItaly

ISS

Sweden

KI

UK

UNIVLEEDS

Hungary

HECRIN

Austria

MUW

Switzerland

SCTO

Iceland

LANSPITALI

Czech Republic

MU

The Netherlands

UMCU

Luxembourg

CRP Sante

Portugal

FCM-UNL

Serbia

SMS

Norway

ST OLAVS

Turkey

DEU

Romania

UMFCV

INRA

Tel Aviv

University

Mario Negri

Institute

CIRM

UnitransferKlinik

Qualissima

FCRB

EURORDIS

UDUS

VSOP

Next steps ?

Legal status

– European Research Infrastructure Consortium ‘ERIC’

– sustainable support by EU countries

– founding members : Germany, Italy, Spain, Portugal, France

Acting as a sponsor ? (instead of service provider to

sponsors)

Acting as the sponsor’s representative in Europe for

trials initiated outside Europe

Developing procedures for international

collaboration

– Identification of obstacles

– Development of tools, establishment of procedures

– Run pilot trials

– Stable partnership agreements with non-EU partners (NIH)