EU-LAC HEALTH 2nd ROADMAPPING Workshop

Transcription

1 EU-LAC HEALTH 2nd ROADMAPPING Workshop ECRIN, its relevance for international collaboration in clinical trials Jacques Demotes / February 26 th, 2014 / Madrid Programme (FP7/ ) under grant agreement n

2 What is the best treatment option for this disease condition? for this group of patients? Clinical trials : o development of innovative health products o exploring new indications for existing drugs o comparative assessment of efficacy and safety of approved healthcare strategies Promoting evidence-based medical practice o scientific medicine International cooperation required: o cost o expertise o access to patients

3 Multinational clinical trials updated infrastructure interoperability high impact projects appropriate funding

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5 ECRIN ERIC 2013 ECRIN IA countries 567M citizens Structuring user communities 5 countries 266M citizens Sustainable infrastructure Programme (FP7/ ) under grant agreement n

6 ECRIN-ERIC and its partners ECRIN ERIC not for profit organisation Scientific Partners (national networks & hubs) MEMBER MEMBER OBSERVER framework contracts on provision and costs of services quality assurance single contract with sponsor third parties PIC MEMBER AFFILIATE PARTNER EC EC Core Team AFFILIATE PARTNER EC NON MEMBER NON MEMBER Data centres

7 Capacity: developing an updated infrastructure, and interoperable tools and procedures

8 Regulatory database Aggregated data (Campus) Navigator (Compass) Merger with Treat NMD database

9 ECRIN certification of data centres

10 ECRIN-IA ( ): structuring pan-european investigation networks

11 Pan-European structuring of biomedical research InnoRARE MuO

12 Operations: support to multinational clinical trials

13 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 Full protocol Scientific evaluation Logistical assessment Contract with sponsor Programme (FP7/ ) under grant agreement n 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.

14 ECRIN trial portfolio LEAN 6S CHILDINN TTM PRECARDIA EuroHYP IMPACTT SafeBoosC STRONG TREAT TRISS EORTC TINN 1 SABATO TINN 2 RESCUE ESES H11 POEM vs LHM ESCALE NeoVitaA ECLIPSE NICO AT B CH CZ DK FIN FR D H IS IRL IT LUX NL NO PL P RO SR SP S TR UK Total 5P 8P 6P 3P 5C, 5P 5P 6C, 5P Programme (FP7/ ) under P = Participating grant agreement countries n C = Coordinating Country 5C, 7P 3P 3P 2P 1C, 11P 1P 1C, 10P 6P 3P 2P 2P 1P 2C, 10P 11P 2P 1C, 10P

15 Funding multinational clinical trials?

16 Follow-up / implementation WG on infrastructure and funding WG on investigator training and certification WG on accreditation of ethics committees WG on patient involvement WG on comparative effectiveness research WG on regulation Programme (FP7/ ) under grant agreement n

17 Global harmonisation of clinical trial regulation including risk based approach risk categories based on marketing authorisation Risk categories phases I II III C I>A I>A A>I B I>A A>I A A>I IV registration New product Modified use Usual care risk based monitoring tech/oecdrecommendation governance ofclinical trials.pdf

18 Partners Dr. Rafael de Andrés(Coordinator) ISCIII, Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Spain Dr. Stephanie Splett Rudolph DLR, Deutsches Zentrum für Luft und Raumfahrt e.v., Germany Dr. Luis Tacsan Chen RIMAIS, Red Iberoamericana Ministerial de Aprendizaje e Investigación en Salud, Ministerio de Salud, Costa Rica Dr. Paulo Buss FIOCRUZ, Fundação Oswaldo Cruz, Brazil Dr. Joaquin Guinea INNOVATEC, Sociedad para el Fomento de la Innovación Tecnológica, Spain Eng. Águeda Menvielle MINCYT, Ministerio de Ciencia, Tecnología Argentina e Innovación Productiva Dr. Gabriela Montorzi COHRED, Council on Health Research for Development, Switzerland /Mexico Dr. Diassina Di Maggio APRE, Agenzia per la Promozione della Ricerca, Italy