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The ESFRI context. Clinical Trials as Instruments supporting Evidence-based Medical Practice.

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. , DC. Washington, DC

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The ESFRI context. Clinical Trials as Instruments supporting Evidence-based Medical Practice.

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  1. Day 3, Wednesday, Embassy of France to the United States of America The ESFRI context. Clinical Trials as Instruments supporting Evidence-based Medical Practice. DrRafael de Andres Medina, Instituto de Salud Carlos III rdam@isciii.es www.isciii.es ,DC

  2. Washington, DC 4 - 6 June 2012 An overview of the context Clinical Trials as Instruments Supporting Evidence-based Medical Practice 2 RDAM

  3. Washington, DC 4 - 6 June 2012 Biological and Medical Sciences [BMS] Research Infrastructures [RI] 2006 2008 • Shouldproviderelevantscientificservices. • Promotecontinuousinnovation. • Business Plan. • Sustainabilityensuredbyselfcommittedmemberstates. • PredictableGovernnance. • Scienceisscientists´ driven. • Fairaccess (no selfservice). • ExternaladvisoryBoard - helicopterview. • Financing and administrationismemberstatedriven. • Usedtohaveeachown legal personnality. • If ERIC, awardedbytheEuropeanCommission, VTA exempt. • ESFRI- SWGsassesstheimplementationand performance 3 RDAM

  4. Washington, DC 4 - 6 June 2012 Biological and Medical Sciences [BMS]Researhc Infrastructures [RI] 2006 2008 2010 • BBMRI - Biobanks • Spain: ISCIIIas funder with 63 biobanks´ network as Scientific partners • EATRIS - Translational Research Facilities • Spain: ISCIII as funder and Health Research Institutes´ networkas Scientific partners • ECRIN - Clinical trial platform • Spain: ISCIII as funder with 40 CRO as Scientific partners • ELIXIR - Bioinformatics • Spain: ISCIII as funder with andINB as Scientific partner • INFRAFRONTIER - Mouse Models and Archives • INSTRUCT - Structural Biology Facilities • EMBRC - Marine Biology Resources • ERINHA - High-security labs • Spain: ISCIII as partner • EuroBioImaging - Cellular and Medical Imaging • EU-Openscreen - Chemical Libraries and Screening • ANAEE - Analysis and experimentation on ecosystems • ISBE – Infrastructure for Systems Biology • EMBRC - European Marine BiologicalResource Centre • MIRRI– Microbial resources 4 RDAM

  5. Washington, DC 4 - 6 June 2012 Strategic Working Groups [SWGs] • Health & Food. • Enviromental & ClimateChange. • Energy. • Social & Cultural Innovation. • InnovationTechnology Transfer. • RegionaI. • Evaluation. • Implementation. 5 RDAM

  6. Washington, DC 4 - 6 June 2012 • Investmentin independentclinicaltrialsbringsmajoraddedvalueforEuropean R&D, healthcaresystems, patientsand citizens. • Needforindependentclinicaltrials. • Needformultinationalcollaboration. • Policymakers´s and publicunderstanding and effectivesupport. 6 RDAM

  7. 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. 7 RDAM

  8. Washington, DC 4 - 6 June 2012 • Basic sciences, particularly the new –omicsmethods, 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. 8 RDAM

  9. Washington, DC 4 - 6 June 2012 • Needforindependentclinicaltrials. • Independentevaluation of healthinterventionsisrequiredtosupporthealthauthorities, develophealthcarepolicies and define clinicalguidelinesforhealthcareprofessionals. • “whatisthebesttreatmentoptionforthispatient / disease ?” • ratherthan • “isthis particular producteffective and safe?” • Highlypositive returnoninvestmentforsociety. • Decreasein theburden of disease, • Optimizedhealthcarestrategies, • Costcontainment in healthcaresystems. “whatisthebesttreatmentoptionforthispatient / disease ?” ratherthan “isthis particular producteffective and safe?”. • Togetrobusterevidence. 9 RDAM

  10. Washington, DC 4 - 6 June 2012 • Needformultinationalcollaboration. • Rapid assessmentof theeffects of treatments. • Largeand diversepopulations. • Widerapplicability of studyresults. • More successfuladoption in nationalhealthcaresystems. • Reduce inequalities in healthcare. • Promotesevidence-basedmedical practice. • Access tolargerpatientpopulations and toclinicalexpertise. • Tostudy of stratified and personnalisedtreatmentstrategies. • Tostudyonrarediseases / conditions. • Access tobestappropriate medical centres. • Roomfor more regulatorycollaborationtoo. 10 RDAM

  11. Washington, DC 4 - 6 June 2012 • We need a common vision and a shared will. Manythanksforyourattention !!! 11 RDAM

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