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Clinical Research in Central Oregon

Clinical Research in Central Oregon. What’s Available to You, to Our Community, and Why. Tim Beard , MD BMC. Archie Bleyer , MD SCHS. Objectives. Objectives. Understand why clinical research is crucial to Central Oregon

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Clinical Research in Central Oregon

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  1. Clinical Research in Central Oregon What’s Available to You,to Our Community, and Why Tim Beard, MDBMC Archie Bleyer, MDSCHS

  2. Objectives Objectives • Understand why clinical research is crucial to Central Oregon • Realize the breadth of clinical trials open to entry at our healthcare facilities • Discover what the IRB is and how it helps assure that our clinical trials are optimal • Anticipate our Clinical Research Center

  3. Objectives • Understand why clinical research is crucial to Central Oregon

  4. * Brings Cutting-Edge Healthcare to Central Oregon SoonerExtraordinary Care close to HomeThe “Latest and Greatest” Examples • Ortho / Neuro / Surgical Devices • Cancer Chemotherapies: Oxaliplatin, … • Anti-thrombosis Treatments • Post-Op Therapy: Alvimopan *Diagnosis, Therapy, Prevention

  5. Brings Cutting-Edge Healthcare to Central Oregon SoonerAlvimopan • Research to standard of care exemplified • Phase 3 trials at BMC and SCMC • Results • Methylnaltrexone?

  6. Brings Cutting-Edge Healthcare to Central Oregon SoonerAlvimopaN • P&T committee • Our study • 3 groups of patients • $4000 per patient hospital savings

  7. Brings Cutting-Edge Healthcare to Central Oregon SoonerA better Warferin (Coumadin)? • Factor Xa Inhibitors

  8. Brings Cutting-Edge Healthcare to Central Oregon SoonerOther EXAMPLES • Sentinal lymph node surgery • Colectomy • Spiral CT for coronary and lung imaging • Respiratory support for premature infants • Thorascopic ablation for atrial fibrillation • Oral therapy for pulmonary hypertension

  9. Progress vs. Safety in Clinical Trials Benefit* Safety* 100 % 100 % 80 % 80 % 60 % 60 % *Personal and Societal

  10. Progress vs. Safety in Clinical Trials Benefit* Safety* 100 % 100 % 80 % 80 % 60 % 60 % *Personal and Societal

  11. Progress vs. Safety in Clinical Trials Clinical Trials Provide Best Balance Raise Benefit & Safety Simultaneously Benefit Safety 100 % 100 % 80 % 80 % 60 % 60 % Patient Management Base By Expanding Patient Management and Raising the Fulcrum

  12. IRB Data Safety Monitoring Board Levels of Review of NCI-Sponsored Clinical Trials Cancer Therapy Evaluation Program and Division of Cancer Prevention* CTSU State of the Science Assessment NCI PIO CRC and IRB Idea Concept Protocol Accruals Results Institutional Research Administration Institutional Leadership Protocol Committee Investigator Modified by A Bleyer from R Comis, ASCO 2002

  13. Multidisciplinary Input and Support of Cancer Clinical Trials Surgery Nursing Radiotherapy Chemotherapy Pharmacy Diagnostic Imaging ClinicalTrial Medical Specialties Pathology Supportive Care Bloodbanking Palliative Care Lab. Med. Research Laboratory

  14. Medical Specialties Input and Support of Cancer Clinical Trials InfectiousDisease Cardiology Gastro-enterology Neurology Nephrology ClinicalTrial Rheumatology Immunology Pulmonology Endocrinology Ophthalmology Derma-tology ENT Psychiatry

  15. Highly-Peer Reviewed Clinical TrialsRaise Benefit & Safety Simultaneously Benefit Safety

  16. 494 hospitals with 174,062 patients with non–ST-segment Acute Coronary Syndrome (ACS) 123 Hospitals 4.9 (3.5-9.7)% on Trial 145 Hospitals 0 Entries 226 Hospitals 1.0 (0.5-1.4)%on Trial Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW Arch Intern Med. 2008;168(6):657-62

  17. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials P = .003 5.9 4.4 In-hospital mortality (%) 3.5 Low Intermediate High Clinical Trial Participation Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW Arch Intern Med. 2008;168(6):657-62

  18. 494 hospitals with 174,062 patients with non–ST-segment Acute Coronary Syndrome (ACS) 123 Hospitals 4.9 (3.5-9.7)% on Trial 145 Hospitals 0 Entries SCMC-B 226 Hospitals 1.0 (0.5-1.4)%on Trial Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW Arch Intern Med. 2008;168(6):657-62

  19. Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials P = .003 5.9 4.4 In-hospital mortality (%) 3.5 SCMC-B Low Intermediate High Clinical Trial Participation Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW Arch Intern Med. 2008;168(6):657-62

  20. Correlation Between Clinical Trial Participation and Hospital OutcomesExample: Non-ST segment myocardial infarction(NSTEMI) 6 4 In-hospital mortality (%) 2 0 0 2 4 6 8 10 % of NSTEMI Patients In ACS Clinical Trials

  21. Negligible and Acceptable Financial Cost to Patients of Participating in Clinical Trials • Cost of treating patients in clinical trials just slightly higher* • Clinical trials appear not to drive up cost of treatment** • 99% of the time, the extra costs are paid by the sponsor (federal, private) and not the patient *www.cancer.gov/clinicaltrials/conducting/developments/notcostly0603 , **…/notcostly0103

  22. Objectives • Understand why clinical research is crucial to Central Oregon • Realize the breadth of clinical trials open to entry at our healthcare facilities and how I and my patients can participate

  23. Specialties Conducting Clinical Research in Central Oregon During Past Decade • Oncology • Cardiology • Orthopedic Surgery • Neurosurgery • Neonatology • Surgery • Neurology • Psychology • Nephrology • Infectious Disease • Immunology • Sleep Disorders • Pulmonology • Trauma • Sports Medicine • Rheumatology • Patient Monitoring Equip. • Pediatrics/Adol. Med. • Acupuncture • Other Integrative Med. • Patient Satisfaction • Rural Health

  24. Breadth of CLINICAL Trials open IN CENTRAL OREGON • Sponsored • National Institutes of Health (NIH) • National Cancer Institute (NCI) • National Heart, Lung and Blood Institute • Universities (OHSU, Portland State) • Private/Corporate Enterprises • Pharmaceutical Industry • Medical (Human) Device Industry • Other Healthcare Systems (e.g. US Oncology) • Investigator-Initiated (N = 8) • IRB Approved • SCHS IRB • Western IRB

  25. CENTRAL OREGON CLINICAL Trials • SCHS Trials April 2009 - March 2010 • 11 healthcare organizations • 921 Central Oregonians currently on trials • 180 patients entered past year • 42 trials open for new subjects • 25 trials closed to entry, in follow-up • BMC Trials • 31 trials open for new subjects • 313 Central Oregonians currently on trials • 89 patients entered past year 1,234 • Total Number of Patients on Trials:

  26. CENTRAL OREGON Investigators • What it takes • Time • Ancillary help • Certified Physician Investigator • Meetings

  27. TYPES OF STUDIES • Phase I • Phase II • Phase III • Phase IV

  28. RISK Evaluation management strategy (rems) • What is it • Is this research?

  29. Clinical trial ENVIRONMENT • How to do it? • What do you need? • Facility • Collaboration

  30. Our Researchers and Their ResearchOncology • Michel Boileau, MD • SELECT • Bill Martin, MD • E5202 • Linyee Chang, MD • AXXENT • Russ Omizo, MD • PRIMA • Steve Kornfeld, MD • S0925 • … • Robert Boone, MD • STAR • ASSURE • TAILORx • IBCSG 24-02 • MA.27 • JMA.17 • S0226 • … • … • … • …

  31. Our Researchers and Their ResearchHeart • John Blizzard, MD • MEND CABG • Tim Hanlon, MD • EXCEED • James Laughlin, MD • VITAL • Jason Wollmuth, MD • SATURN • Chris Hatlestad, MD • TACT2 • Bruce McClellan, MD • AFIB • COMM AFIB • OASIS • LUNAR • … • Michael Widmer, MD • ASCEND • LGVX • LGVY • RED-HF

  32. Our Researchers and Their ResearchOrthopedic Surgery / Physical Therapy • Cara Walther, MD • KNEEBOUND • Viviane Ugalde, MD • SQUAT TEST • Brett Gingold, MD • OP1 Implant • Kathleen Moore, MD • OP1 Putty • Anthony Hinz, MD • GEM • Robert Thomas, MD • LFIT • Knute Buehler, MD • CECT • EXETER • … • James Verheyden, MD • ASCENSION MCP, PIP • Scott Jacobsen, MD • AEQUALIS • Michael Coe, MD • AVANTA • David Stewart, MD • ALVIMOPAM

  33. Our Researchers and Their ResearchNeurosurgery • Raymond Tien, MD, PhD • SAPPHIRE • NEUROFORM • Mark Belza, MD • CERVDISC • TILF • Brad Ward, MD • COAST • KAVIAR • Kent Yundt, MD • OP1Putty

  34. Our Researchers and Their ResearchOther Specialties • Stephen Archer, MD • BOLD • Susan Gorman, MD • MWEndometAblation • Adiana • Linda Leffel, MD • BreastImplant • David Dedrick, MD • RestlessLegs • Patrick McCarthy, MD • AGREE • Endure • Francis McCabe, MD • WELCH ALLYN • Brian O’Hollaren, MD • ALVIMOPAM • Todd Tornay, MD • ED Dx • Teresa Chianello, PhD • MUPS • Travis Monchamp, MD • SanofiiAventisEFC • Lyle Fagnon, MD • CLEMENTE

  35. Our Researchers and Their ResearchBend Memorial Clinic • Tim Beard, MD • MNTXHernia • MNTXColec • Pozen • Adolor cystectomy • BRI DVT • Pozen Endo • I3 POI • Darren Kowalski, MD • LAPCOLON • Bill Schmidt, MD • GSK Magrit • Eclipse • Pfizer Breast • Clovis Pancreatic • Ted Braich, MD • ACORN • Gavin Noble, MD • Borealis • Aspect

  36. Our Researchers and Their ResearchBend Memorial Clinic(continued) • Mike Feldman, MD • Mitsubishi KRM • Luitpoldanemia • Matt Lasala, MD • Genentech Stage • Roche Emerge 6 • Genentech Sundial • Roche Emerge 8 • BRI COPD • Adam Williams, MD • Forest COPD • Greg Borstad, MD • Takeda Gout • Lilly BCDO • Abbott RA • Rich Koch, MD • Lilly Taby • IELCAP • Mike Harris, MD • ICON/BMS • Rob Matthews, MD • NIAON

  37. Our Researchers and Their ResearchBend Memorial Clinic(continued) • Jon Lutz, MD • WESTNILE • Mary Carroll, MD • Takeda SYR-322 • Trial Net DM • Lilly GBDA • Lilly IOQC • Karen Oppenheimer, MD • Daiichi Engage Total: 54 MD & MD/PhD Principal Investigators

  38. SCHS Research Coordinators • NouraSall, MS, CCRCAndrea Andrus, CCRC, RDCSAimee Soles, CRA Cardiovascular Services, SCHS • Meredith Dawson, CCRCThe Center for Orthopedic and Neurosurgical Care and Research • Megan Boone, CRAKristi Sterry, CCRPCancer Center, SCHS

  39. Research Coordinators (continued) • Karla Lichter, MS, CCRCPamela Gogenola, CCRCJoanne Smith, CCRCChristine Reed, BS, CCRCAaron Pratt, BS, CRCJennifer McCormick, MA CRCMolly JohnsonDanielle QuinlinAnne BerginJoanne SmithBend Memorial Clinic

  40. Research Coordinators (continued) • TBAAdvanced Specialty Care • Sara McCarthyNW Endocrinology Total: 17 Research Coordinators

  41. Research Coordinators Ex Officio • Karen Doolan, RN, NP, CRATeddy Richardson, RN, CRAHeart Institute of the Cascades • Deb Rogers , RN, NP, CRAThe Center for Orthoppedic and Neurosurgery Care and Research • Janice McDaniel, CCRPSCHS Cancer Center

  42. Objectives • Understand why clinical research is crucial to Central Oregon • Realize the breadth of clinical trials open to entry at our healthcare facilities • Discover what the IRB is and how it helps assure that our clinical trials are optimal

  43. History and Ethics • Nuremburg Code (WWII) • Wichita Jury Case (1953) • Milgram “Obedience to Authority” (1963) • Declaration of Helsinki (1964) • Beecher Report (1966) • PHS Tuskegee Syphilis (1932-1971) • Humphrey “Tea Room Trade” (1970) • Zimbardo “Simulated Prison” (1973) • Belmont Report (1979) Respect for Persons Beneficence Justice

  44. International (ICH) • Federal (DHHS, FDA, etc.) • State • Local regulations 45CFR46 21CFR5021CFR56 SCHS Insitututional Review Board (IRB) Legally mandated to assure that 1) The conduct of all research activities involving humans or specimens from humans within the SCHS is in compliance with

  45. SCHS Insitututional Review Board (IRB) • The rights and welfare of our people willing to participate in clinical research are protected • The risks, discomforts and inconveniences of the research is justified relative to potential individual and societal benefit • All subjects are fully informed and freely consent • All human subject researchand research proposals at SCHS is reviewed and approved • IRB includes scientists and community members

  46. SCHS IRB • Founded: 1988 • Studies approved: 330+since 1994 • Prior Chairs • Michel Boileau, MD • Bruce Brundage, MD • Derek Gillespie, PharmD • Mary Jane Kuhar, MD • Robert Boone, MD • Steve Meyer, MD • Allen Merritt, MD

  47. SCHS IRB Other Prior Members • Keith Harless, MD • Christopher Clark, MD • John Rask, MD • Bryce Yerman, MD • Craig Miller, MD • Darius Azin, MD • Cherri McKenzie, RN • Dorothy Barrow, RN • James Hurley, JD • Rick Martin, BS • Ellen Eisman, PhD • Alan Burke, MSW • Dave Vial, PharmD • Rose Dusen-Speck, LPT • Barton Clements, EdD

  48. SCHS IRB Other Prior Members(continued) • Jay Casbon, PhD, CEO & Provost emeritusOregon State University – Cascades Campus • Bryan Gruetter, JD,Attorney, GruetterLaw • Jana Jaderborg, MD, Surgeon, Advanced Specialty Care • Dana McClintock, MD, Bend Research Inc. • Justin Sangani, PharmD, Research Pharmacist • Peggy Carey, RN, MPA, Cancer Program Director

  49. SCHS IRB 2011 • Archie Bleyer, MD, Chair • Bill Danaher, Spiritual Care • Robert Cutter, PharmD, Pharmacy 8 Members SCHS Members

  50. SCHS IRB 2011 Community Members • Katie Richards, MD, Chair AlternateEmergency Medicine • James Ritzenthaler, MD, Internist, Director, Volunteers in Medicine • David Lyon, PhD, Vice President, Physical and Biological Sciences, Bend Research Inc. • Adam Carroll, PhD, Bend Research Inc. • Michael Gibson, BS, Patient Advocate

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