Day 3, Wednesday,
Embassy of France to the United States of America
The ESFRI context.
Clinical Trials as Instruments supporting Evidence-based Medical Practice.
Dr Rafael de Andres Medina, Instituto de Salud Carlos III rdam@isciii.e
s www.isciii.es
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2006
2008
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Biological and Medical Sciences [BMS]
Research Infrastructures [RI]
 Should provide relevant scientific services.
 Promote continuous innovation.
 Business Plan.
 Sustainability ensured by self committed member states.
 Predictable Governnance.
 Science is scientists ´ driven.
 Fair access (no self service).
 External advisory Board - helicopter view.
 Financing and administration is member state driven.
 Used to have each own legal personnality.
 If ERIC, awarded by the European Commission, VTA exempt.
 ESFRI
- SWGs assess the implementation and performance
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Biological and Medical Sciences [BMS]
Researhc Infrastructures [RI]
2006
 BBMRI - Biobanks
 Spain: ISCIII as funder with 63 biobanks ´ network as Scientific partners
 EATRIS - Translational Research Facilities
 Spain: ISCIII as funder and Health Research Institutes ´ network as Scientific partners
 ECRIN - Clinical trial platform
 Spain: ISCIII as funder with 40 CRO as Scientific partners
 ELIXIR - Bioinformatics
 Spain: ISCIII as funder with and INB as Scientific partner
 INFRAFRONTIER - Mouse Models and Archives
 INSTRUCT - Structural Biology Facilities
2008  EMBRC - Marine Biology Resources
 ERINHA - High-security labs
 Spain: ISCIII as partner
 EuroBioImaging - Cellular and Medical Imaging
 EU-Openscreen - Chemical Libraries and Screening
2010  ANAEE - Analysis and experimentation on ecosystems
 ISBE – Infrastructure for Systems Biology
 EMBRC - European Marine Biological Resource Centre
 MIRRI – Microbial resources
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Strategic Working Groups
[SWGs]
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 Investment in independent clinical trials brings major added value for European
R&D, health care systems, patients and citizens .
 Need for independent clinical trials.
 Need for multinational collaboration.
 Policy makers ´ s and public understanding and effective support .
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 The goal of evidence-based medicine.
 It applies not only for medicinal products, but also for medical devices.
 Other non-pharmacological interventions, e.g. rehabilitative procedures and surgical techniques, require comparative clinical trials too.
 e.g. Relevant in Multi-morbidity / poly-pathology of ageing populations that will require therapeutic combinations.
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 Basic sciences, particularly the new –omics methods, are leading to an important change in the nomenclature of diseases .
 What was considered a single disease is now dissected into various strata.
• Relevat for distinct diagnostic and prognostic features .
 Prevention and predictive medicine.
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 Need for independent clinical trials.
 Independent evaluation of health interventions is required to support health authorities, develop health care policies and define clinical guidelines for healthcare professionals.
“is this particular product effective and safe?” .
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 Highly positive return on investment for society.
 Decrease in the burden of disease,
 Optimized health care strategies,
 Cost containment in health care systems.
 To get robuster evidence.
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 Need for multinational collaboration.
 Rapid assessment of the effects of treatments .
 Large and diverse populations.
 Wider applicability of study results.
 More successful adoption in national health care systems.
 Reduce inequalities in health care.
 Promotes evidence-based medical practice.
 Access to larger patient populations and to clinical expertise.
 To study of stratified and personnalised treatment strategies.
 To study on rare diseases / conditions.
 Access to best appropriate medical centres.
 Room for more regulatory collaboration too.
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