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Advancing Evidence-Based Clinical Trials for Medical Innovation

Explore the role of Clinical Trials in Evidence-Based Medicine. Dive into the importance of multinational collaboration, independent evaluations, and fostering innovation in healthcare practices. Learn about prestigious research infrastructures and the strategic working groups shaping the future of healthcare. Join us to discover the transformative power of robust clinical trials and the journey towards personalized treatment strategies.

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Advancing Evidence-Based Clinical Trials for Medical Innovation

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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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