05/09/2015 European Clinical Research Infrastructures Network .

19/04/2319/04/23 www.ecrin.orgwww.ecrin.org 11

European Clinical Research Infrastructures Network

www.ecrin.org


Challenges to clinical research Challenges to clinical research in Europein Europe

Main Main bottlenecks : bottlenecks :

– Access to patients: Access to patients: fragmentation of health systemsfragmentation of health systems

– Cost: Cost: fragmentation of public fundingfragmentation of public funding

– Quality of infrastructuresQuality of infrastructures


Comparison of national requirements EC CA sponsor insurance AER


ECRIN proposalsECRIN proposals Integration of EU clinical research capacityIntegration of EU clinical research capacity

– support to investigatorssupport to investigators– support to sponsors in multinational studiessupport to sponsors in multinational studies

-> unlocking latent potential : scientific, patients-> unlocking latent potential : scientific, patients Integration of public fundingIntegration of public funding

-> avoiding duplication of studies & wasting of -> avoiding duplication of studies & wasting of moneymoney

Harmonisation of tools, training and practiceHarmonisation of tools, training and practice Improved quality, credibility, transparencyImproved quality, credibility, transparency ----> harmonisation of legislative systems ?----> harmonisation of legislative systems ?


Which clinical research projects Which clinical research projects ??

Any type of clinical researchAny type of clinical research– Clinical trials on health products, biotherapyClinical trials on health products, biotherapy– Surgery, radiotherapy, multimodal trialsSurgery, radiotherapy, multimodal trials– Diagnostic, imaging, biomarker, genetic studiesDiagnostic, imaging, biomarker, genetic studies– Physiology, physiopathology, epidemiologyPhysiology, physiopathology, epidemiology

Any medical fieldAny medical field Special focus on rare diseases / orphan drugsSpecial focus on rare diseases / orphan drugs Any sponsor : public institution, public-private Any sponsor : public institution, public-private

partnership, biotechnology & medical device partnership, biotechnology & medical device SMEs, pharmaceutical industrySMEs, pharmaceutical industry

-> support to investigators-> support to investigators -> support to sponsors in multinational studies-> support to sponsors in multinational studies


ECRIN, an integrated ECRIN, an integrated infrastructure for clinical trials infrastructure for clinical trials

in the EUin the EU ECRIN-1 (2004-2005) : ECRIN-1 (2004-2005) :

Identifying bottlenecksIdentifying bottlenecks

ECRIN-2 (2006-2008) :ECRIN-2 (2006-2008) :

Design of the infrastructureDesign of the infrastructure

ECRIN-3 (2008 -> ) : ESFRI roadmapECRIN-3 (2008 -> ) : ESFRI roadmap

Preparation, construction and operation Preparation, construction and operation

of the infrastructure supporting of the infrastructure supporting

multinational clinical trials in the EUmultinational clinical trials in the EU

In line with expectations of FP7 In line with expectations of FP7

‘‘Innovative Medicines Initiative’Innovative Medicines Initiative’


ECRIN-1 (2004-2005) : ECRIN-1 (2004-2005) : identifying bottlenecks identifying bottlenecks

ECRIN-RKP (FP6-funded): -> survey and comparative analysis on

1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, insurance 5 - Adverse event reporting, drug dispensing6 - Methodology, data management, data monitoring7 - Quality management, SOPs, audits 8 - Communication, partnerships 9 - Study registers 10 - Education and careers

-> reports on www.ecrin.org


ECRIN-2 (2006-2008) :ECRIN-2 (2006-2008) :designing the infrastructuredesigning the infrastructure

ECRIN TWG (FP6-funded)ECRIN TWG (FP6-funded)

TRANSNATIONAL WORKING GROUPS : TRANSNATIONAL WORKING GROUPS : -> Guidelines and procedures-> Guidelines and procedures

1 - ethics 1 - ethics 2 - regulation 2 - regulation 3 - adverse event reporting3 - adverse event reporting4 - data management4 - data management5 - monitoring5 - monitoring6 - quality assurance 6 - quality assurance –– SOPs SOPs7 - education7 - education


ECRIN-3 (2008-) : Integrated ECRIN-3 (2008-) : Integrated services to multinational studiesservices to multinational studies

Flexible, integrated services (one-stop shop) in the Flexible, integrated services (one-stop shop) in the conduct of the studyconduct of the study

1 - interaction with ethics commitees1 - interaction with ethics commitees

2 - interaction with competent authorities, regulatory affairs2 - interaction with competent authorities, regulatory affairs

3 - drug dispensing3 - drug dispensing

4 - adverse event reporting4 - adverse event reporting

5 - data management 5 - data management –– data centres data centres

6 - study monitoring6 - study monitoring

7 - circulation and storage of blood and tissue samples7 - circulation and storage of blood and tissue samples

8 - GMP manufacturing of biotherapy products8 - GMP manufacturing of biotherapy products

9 - patients recruitment and investigation9 - patients recruitment and investigation


ECRIN-3 (2008-) : Integrated ECRIN-3 (2008-) : Integrated services to multinational studies (2)services to multinational studies (2)

Information and consulting during the preparation of Information and consulting during the preparation of the studythe study1 - Methodology, protocol review and adaptation of 1 - Methodology, protocol review and adaptation of

study protocol to transnational constraintsstudy protocol to transnational constraints2 - Ethical review2 - Ethical review3 - Meta-analysis 3 - Meta-analysis 4 - Centre selection, stimulation of patients4 - Centre selection, stimulation of patients ’’

enrolmentenrolment5 - Cost evaluation5 - Cost evaluation6 - Funding opportunities6 - Funding opportunities7 - Biostatistics7 - Biostatistics8 - Data safety and monitoring committees8 - Data safety and monitoring committees9 - Insurance9 - Insurance


FranceInserm

Spain SCReN

SwedenSweCRIN

GermanyKKS

DenmarkDCRIN

ItalyIRFMN & CIRM

HungaryHECRIN

UKUKCRN

Ireland ICRIN

EFGCP

National networks of Clinical Research Centres / Clinical Trial Units

AustriaATCRIN

SwitzerlandSCRN

EORTC

FinlandFinnCRIN


CRC= Clinical research centreDC= Data centre EC= European CorrespondentGMP= GMP facility for biotherapy NNC= National Network Coordination

NNC

ECRIN

DC CRC

CRC

EC

GMP CRC

CRC

CRC

DC

CRC

CRCGMP

CRCCRCCRC

CRCCRC

GMP

CRC

CRC

NNC

NNC

NNC

NNC

NNC

ECEC

EC

EC

EC


Synergies with other ESFRI Synergies with other ESFRI InfrastructuresInfrastructures

EATRIS

Bioinformatics

INFRAFRONTIERClinical Trials

Biotherapy

Biobanks

Biomolecular

Resources

Structural

Biology

Target Id

Target Val Hit Lead

LeadOptim Preclin Phase I Phase II

Research Discovery Development

Phase III

biobanking

model validation

samples

data

biomarkers

samples

data

targets

biomarkers

targets


Infrastructures for preclinical R&D: toxicology models and databases, biopharmaceutical manufacturing facilities

Research networksInvestigators networks

Patients’ registries

Infrastructures for multinational clinical research :clinical research centres, cohorts, biobanks, databanks, imaging

Infrastructures for drug discovery: high throughput‘omic’ facilities, in silico and animal models

cancer brain diabetes inflammation infectionEU-wide infrastructures networks

Clinical(ECRIN)

Preclinical

Drug discovery

EU-wide disease-oriented networks

FP7 IMI : Europe-wide infrastructures FP7 IMI : Europe-wide infrastructures and disease-oriented networksand disease-oriented networks

05/09/2015 European Clinical Research Infrastructures Network .

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