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Judy Cherry, RN, CCRC Director, CV Research FHC Fuqua Heart Center

L eading Edge Therapy: Beyond the Academic Institution….the Community Frontier “ Clinical Research: New Approaches to Common Problems”. Judy Cherry, RN, CCRC Director, CV Research FHC Fuqua Heart Center. Focus of this Presentation. Introduce you to the Fuqua Heart Center

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Judy Cherry, RN, CCRC Director, CV Research FHC Fuqua Heart Center

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  1. Leading Edge Therapy: Beyond the Academic Institution….the Community Frontier “Clinical Research:New Approaches to Common Problems” Judy Cherry, RN, CCRC Director, CV Research FHC Fuqua Heart Center

  2. Focus of this Presentation Introduce you to the Fuqua Heart Center Cardiovascular Research Department

  3. New ApproachesClinical Trials • Improve patient outcomes • Improve quality of care • Enhance systems efficiency • Inform health policy

  4. Ultimate Goal? Translation of results from clinical studies into everyday clinical practice and health decision-making Institute of Medicine; Clinical Research Roundtable October 2004

  5. FHC Research Infrastructure Clinical Operations Regulatory

  6. CV RESEARCH MEDICAL CO-DIRECTORS

  7. FHC Research Environment • Experienced Research Team • Accessibility of a large, well characterized, stable patient base • Reputation as a leading center for cardiovascular care • Supportive, interdisciplinary service line • “Track record” of excellent performance by the Investigators & the Institution

  8. Clinical Well-trained study coordinators are a key success factor …the individual responsible for day-to-day trial activities. ensures standards are met • Communicate • Market • Recruit • Consent • Audit • Educate

  9. Regulatory FDA conducts audits on >700 clinical investigator sites, 250 IRBs & 100 CROs each year • Multiples levels of protection of research subjects • Guidelines & SOP’s for conducting trials • Conduct routine QA • Prepare for audits • Day-to-day regulatory activities

  10. Operations • Study Budgeting • Contract Negotiations • Billing and Coding Compliance • Financial Tracking (Receivables/Payables) • Operational Analysis/Department Budgeting

  11. Specialized Disciplines • Coronary Intervention • Arrhythmia Center • Peripheral Vascular Intervention • Cardiovascular Surgery • Cardiac Imaging Center • Prevention • Medical Therapy • Heart Failure

  12. Coronary Intervention • Next generation drug-eluting stents • Diabetes & cardiovascular disease • Distal protection devices • Infarct management

  13. Arrhythmia Center • Cardiac resynchronization for CHF • Atrial fibrillation • Ablation for complex arrhythmias • Sudden death prevention • Post MI pacing for remodeling prevention

  14. Peripheral Vascular Intervention Stents • Renal • Iliac & SFA • Carotid artery

  15. Cardiovascular Surgery • Anti-thrombotic therapy • Anti-inflammatory therapy • Valve Procedures

  16. CMR Cardiac structure Cardiac function Perfusion and infarction Valves, shunts Angiography Plaque imaging CCT Coronary artery calcium Coronary CTA Peripheral CTA Cardiovascular MR and CT (CMR/CCT)

  17. Prevention • Metabolic syndrome • Genomics • Dyslipidemia • Advanced CAD management • Genomic Metabolic Registry

  18. Medical Therapy • CHF • Diabetes & cardiovascular disease • Anti-thrombotic therapy • Anti-anginal therapy • Other combination cardiovascular therapy

  19. Clinical Investigation: The Partnership • FHC/Piedmont Hospital • Community Physicians • Universities • Industry • Government Agencies • Non-Profit Agencies

  20. “There is little point in devoting time, financial resources, and a vast Human effort to clinical trials unless we all heed their results. Here is perhaps the single most important challenge for present and future trialists.” Richard Horton, MD Curtis Meinert Honorary Keynote Address Society for Clinical Trials, 2001

  21. Why Research? The time efficiency of providing potentially live saving technologies to society is crucial…lives literally depend on this process.

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