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Collaboration for Cardiac Safety Research in Children: CSRC View

Learn about the Cardiac Safety Research Consortium (CSRC) and their mission to address therapeutic innovation and cardiac safety in children. Discover the collaborative efforts, partnerships, and consensus-building initiatives to enhance pediatric cardiac safety research.

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Collaboration for Cardiac Safety Research in Children: CSRC View

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  1. Collaboration, Cardiac Safety And Children:The Cardiac Safety Research Consortium (CSRC) View Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute

  2. Cardiac Safety Research Consoritum (CSRC) Mission, who we are, how we work

  3. Addressing Therapeutic Innovation in the USA 2004 R&D Spending & New Rx Applications 10 Year Trends http://www.fda.gov/oc/initiatives/criticalpath/

  4. Cardiac Safety in Regulatory Science: Rare but catastrophic events 2006 FDA-Duke MOU Cardiac Safety Research Consortium

  5. NEUTRAL GROUND • COMMITMENT • ADM. INFRASTRUCTURE: • HELP ESTABLISH WG/SC • CONTRACTS MGNT • COORDINATE MEETINGS • FINANCIAL OVERSIGHT The CSRC Public-Private Partnership MODEL FDA INDUSTRY Mortara Instrument CRADA ACADEMIA PT. GROUPS PUBLIC-PRIVATE CONSORTIUM DCRI MOU PROFESSIONAL ORGANIZATIONS PPP STEERING COMMITTEES WORKING GROUPS NON-PROFIT STATE, OTHER • IDENTIFY MUTUAL PRORITIES • POOL RESOURCES/EXPERTISE • DEFINE ROLES/RESPONSIBILITIES • GAP ANALYSES (WHAT’S KNOWN?) • CO-DEVELOPPROPOSALS • BUDGETS • TIMELINES • RFPs IMPLEMENT PROJECTS

  6. Partnering Organizations • DIA • HESI • ACC-NCDR • ICOS • NIH • AHA • FDA • Health Canada • PMDA Japan

  7. Member Companies 2016 • Monebo • MortaraInsrument • Merck • Nabios GmbH • OBS Medical • Perspective Informatics • Pfizer, Inc • Portola • Quintiles • Roche • Salix • Sanofi Aventis • Takeda • Taylor Microtech • Vince & Associates • Abbott • AbbVie • AliveCor • Amgen • AMPS • Astra Zeneca • AlCor • Bayer • Bioclinica • Biomedical Systems • BoehringerIngelheim • Cardiocore • CardioNet • Celerion • Chiesi Pharma • CytoVas • Dabi, Ltd • Daiichi • Duck Flats Pharma • Eli Lilly • Epidemico • Gilead Sciences • G.E. Health Care • Global Instrumentation • GlaxoSmithKline • InVivoSciences • Johnson & Johnson • Medifacts • Medpace • Medtronic • Merck

  8. CSRC Basics • Regulatory mission: CV safety concerns • Unique partnership of stakeholders • Dialogue • Collaboration & trust • Consensus • Thinktank/incubators: • To talk and to listen • To do….

  9. CSRC Consensus White Papers

  10. CSRC 2006-2016 Ten Year Report

  11. Pediatric Drug & Device Safety: 2010 A Complex Equipoise

  12. Complexities of Pediatric Safety:“Normal” from conception thru adolescence • A matrix of change: • Growth • Metabolic • Hormonal • Psychosocial development • Exercise and exertion • Drugs and devices • On-target and off-target effects • Ethical considerations & research (consent)

  13. September 30, 2014 NCAA Cardiac Task Force MeetingIndianapolis September 23-24, 2014

  14. Technology use • False positives • False negatives • Additional testing • Developmental impact • Quality • Cost Maron B et al, Circulation. 2014;130:1303-1334 Lawless C et al, JACC. 2014;60:2146-71

  15. CSRC Consensus Focus on Pediatric Safety:Unmet needs for screening & for therapeutic innovations • Defining “normal” • Most kids screened are normal variants • Enhanced definition of normal enhance detection of abnormal (sensitivity & specificity) • “Normal” kids is an information signature, not a single technology • Understanding “normal” in kids requires follow-up

  16. CSRC: Developing consensus in place of contention • Start with what’s easiest: • To agree upon • To do • Tolerate imperfection • Listen for what we can do together that no one of us could do alone

  17. Screening: what can we all easily agree to? • Screening programs are active nationally: • Private foundations • Academic centers • NCAA • Primary “flaw” in national screening: inconsistency • We can do better working together than any one can do separately • What’s good for screening (normals) is good for regulatory • We can get better without being perfect

  18. What could we make better (not “perfect”)? • Automate technology wherever possible • Blood pressure • ECG • Echo • Lower cost, higher consistency data • Enhance consistency of data content/structure across actice screening efforts • Define contemporary, age-related “normals” criteria • Automate follow-up wherever possible • I-phone apps • EHR For insight into “healthy”

  19. Collaboration, Cardiac Safety And Children:The Cardiac Safety Research Consortium (CSRC) View Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute

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