Clinical Trials as Instruments supporting Evidence

Report
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
[email protected]
www.isciii.es
, DC
Washington, DC
4 - 6 June 2012
An overview of the context
Clinical Trials as Instruments
Supporting Evidence-based
Medical Practice
RDAM
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Washington, DC
4 - 6 June 2012
2006
2008
RDAM
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]
2006
 BBMRI - Biobanks

Researhc Infrastructures [RI]
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

RDAM
EMBRC - European Marine Biological Resource Centre
 MIRRI – Microbial resources
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Strategic Working Groups
[SWGs]








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Health & Food.
Enviromental & Climate Change.
Energy.
Social & Cultural Innovation.
Innovation Technology Transfer.
RegionaI.
Evaluation.
Implementation.
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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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Washington, DC
4 - 6 June 2012
 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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Washington, DC
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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.
“what is the best treatment option for this patient / disease ?”
rather than
“is
“isthis
thisparticular
particularproduct
producteffective
effective and
andsafe?”
safe?”.
 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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Washington, DC
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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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Washington, DC
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 We need a common vision and a shared
will.
Many thanks for your attention !!!
RDAM
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