EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 281459.

EU-LAC HEALTH “2nd ROADMAPPING Workshop”

ECRIN, its relevance for international collaboration in clinical trials

www.ecrin.org

Jacques Demotes / February 26th, 2014 / Madrid

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

What is the best treatment option for this disease condition ? for this group of patients ?

Clinical trials :o development of innovative health productso exploring new indications for existing drugso comparative assessment of efficacy and safety of

approved healthcare strategies

Promoting evidence-based medical practiceo ‘scientific medicine’

International cooperation required:o costo expertiseo access to patients

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Multinational clinical trials

updated infrastructure interoperability

high impact projects appropriate funding

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 281459.

ECRIN ERIC 2013

5 countries266M citizensSustainableinfrastructure

ECRIN IA 2012‐1623 countries567M citizensStructuring user communities

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

ECRIN-ERIC and its partners ECRIN ERIC not‐for‐profit organisation

Scientific Partners (national networks & hubs)

framework contracts on provision and costs of 

services quality assurance

single contract with sponsor third parties PIC 948646712

CoreTeam

AFFILIATEPARTNER

AFFILIATEPARTNER

OBSERVER

NONMEMBER

NONMEMBER

MEMBER

MEMBER

MEMBER

EC

EC EC

Data centres

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Capacity: developing an updated infrastructure, and

interoperable tools and procedures

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Merger withTreat‐NMD database

Aggregated data(Campus) 

Navigator (Compass)

Regulatory database

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

ECRIN certification of data centres

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

ECRIN-IA (2012-16): structuring pan-European investigation networks

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Pan-European structuring of biomedical research

InnoRARE MuO

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Operations: support to multinational clinical

trials

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 281459.

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 trial units

• Information on insurance • Information on cost and

funding opportunities• Information on

contracting• Adaptation to local

context• Methodological support

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

Scientificevaluation

Logisticalassessment

Contractwith sponsor

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 281459.

AT B  CH  CZ  DK  FIN FR D H IS IRL IT LUX NL  NO  PL  P  RO  SR  SP S  TR  UK LEAN 

6S 

CHILDINN

TTM 

PRECARDIA 

EuroHYP 

IMPACTT 

SafeBoosC 

STRONG TREAT 

TRISS 

EORTC  40091 

TINN 1 

SABATO 

TINN 2 

RESCUE ESES 

H11 

POEM vs LHM 

ESCALE 

NeoVitaA 

ECLIPSE 

NICO 

Total  5P 8P  6P  3P  5C, 5P  5P  6C, 

5P 5C, 7P   3P   3P  2P  1C, 

11P  1P  1C, 10P   6P  3P 2P  2P  1P  2C, 

10P   11P  2P  1C, 10P 

P = Participating countries C = Coordinating Country

ECRIN trial portfolio

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Funding multinational clinical trials ?

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 281459.

www.oecd.org/sti/sci‐tech/49344626.pdf

Follow-up /implementation

WG on infrastructure and funding

WG on investigator training and certification

WG on accreditation of ethicscommittees

WG on patient involvement

WG on comparative effectiveness research

WG on regulation

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Global harmonisation of clinical trial regulation

including risk‐based approach

risk categories based on marketing authorisation

risk‐based monitoring

www.oecd.org/sti/sci‐tech/oecd‐recommendation‐governance‐of‐clinical‐trials.pdf

New product Modified use

registrationphases    I                 II             III   IV

I>A A>IA>I

I>AI>A

C B ARisk categories

A>I

Usual care

EU-LAC HEALTH has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 281459.

Dr. Rafael de Andrés(Coordinator)ISCIII, Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Spain

Dr. Luis Tacsan ChenRIMAIS, Red Iberoamericana Ministerial de Aprendizaje e Investigación en Salud, Ministerio de Salud, Costa Rica

Dr. Joaquin GuineaINNOVATEC, Sociedad para el Fomento de la Innovación Tecnológica, Spain

Dr. Gabriela MontorziCOHRED, Council on Health Research for Development, Switzerland /Mexico

Dr. Stephanie Splett‐RudolphDLR, Deutsches Zentrum für Luft‐ und Raumfahrt e.V., Germany

Dr. Paulo BussFIOCRUZ, Fundação Oswaldo Cruz, Brazil

Eng. ÁguedaMenvielleMINCYT, Ministerio de Ciencia, TecnologíaArgentina e Innovación Productiva

Dr. Diassina Di MaggioAPRE, Agenzia per la Promozione della Ricerca,Italy

Partners