Karen Marder, M.D., Professor of Neurology, Columbia University

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  • This is right out of the grant. For 36 years research was confined to specific areas - initially PH4 and Vanderbilt 3, and then when the Irving Center was created, the adult inpatient and outpatient units moved to PH10. Pediatric outpatients have been seen in VC3 since that time. The dedicated unit in Babies hospital no longer exists, and research beds are now dispersed throughout childrens' hospital CER partnership will involve working together in the ED to enhance pre-ED work, ACNCs which are technically off-site but are an area of joint concern.
  • Karen Marder, M.D., Professor of Neurology, Columbia University

    1. 1. Irving Institute for Clinical and Translational Research Home for Columbia’s Clinical and Translational Science Award
    2. 2. <ul><li>Adult Inpatient </li></ul><ul><li>Adult Outpatient </li></ul><ul><li>Pediatric Inpatient </li></ul><ul><li>Pediatric Outpatient </li></ul><ul><li>SLRHC: Inpatient and Outpatient </li></ul><ul><li>Core Laboratory </li></ul><ul><li>Bionutrition Core </li></ul><ul><li>Informatics Core </li></ul><ul><li>Biostatistics Resource </li></ul>Our Structure: A Comprehensive, Broad Based GCRC
    3. 3. Support for Research and Training <ul><li>75 Investigators and their staffs </li></ul><ul><li>80-100 protocols </li></ul><ul><li>2000-2005: 600 peer reviewed papers, reviews, chapters </li></ul><ul><li>K30 Award : MS in Biostatistics: Patient Oriented Research (40 graduates since 1999; 16 active students) </li></ul><ul><li>K12 Scholars Award : (4 graduates since 2003; 3 carryover scholars): 75% salary support plus research funds </li></ul>
    4. 4. Limitations of the GCRC <ul><li>Surrounded by walls </li></ul><ul><li>Limited core support services </li></ul><ul><li>Limited training funds </li></ul><ul><li>No mission to affect the way research is conducted </li></ul>
    5. 5. Our Mission <ul><li>Train and mentor a new generation of multidisciplinary C/T investigators </li></ul><ul><li>Expand and optimize the utilization of outstanding new and existing resources at CUMC </li></ul><ul><li>Support pre-clinical and clinical departments in the recruitment and retention of outstanding C/T investigators at CUMC </li></ul><ul><li>To change the way people think about and conduct research at CUMC </li></ul>
    6. 6. Biomedical Informatics Stephen Johnson PhD Organizational Chart Regulatory Knowledge And Ethics John Ennever MD Paul Appelbaum MD Ruth Fischbach PhD Translational Technologies Henry Ginsberg MD Community Engagement Rafael Lantigua MD B. Boden-Albala PhD Pilot And Collaborative Study Award Nancy Reame RN PhD Training and Nurturing Scientists for Research That is Multidisciplinary Melissa Begg ScD Karina Davidson PhD Tracking Evaluation Mark Graham PhD Harold Pincus MD Zoon Naqvi PhD Leslie McHale Associate Director Programs Jo-Ann Espaillat Associate Director Finance Biomarkers Core John O’Connor PhD Botanical Analysis Core Fredi Kronenberg PhD Clinical Genetics Core Angela Christiano PhD Rudolph Leibel MD PhD Imaging Core John Mann MD Organic Synthesis Core Donald Landry MD PhD Research Pharmacy Robert Macarthur PharmD Clinical Research Center Karen Marder MD MPH Michael Rosenbaum MD Sudha Kashyap MD Jeanine Albu MD Irving Institute Henry Ginsberg MD Melissa Begg ScD Karina Davidson PhD Nancy Green, PhD Harold Pincus, MD Design and Biostats Roger Vaughan DrPH William Friedewald MD Annetine Gelijns PhD Development of Novel Methods Henry Ginsberg MD Harold Pincus MD
    7. 7. Regulatory Issues <ul><li>4 IRBs </li></ul><ul><ul><li>CUMC, NYS Psychiatric Institute, WIRB, St. Lukes- Roosevelt </li></ul></ul><ul><li>CTSA Advisory Committee Review is not integrated with IRB review </li></ul><ul><li>2 CTSAs (Columbia and Weill Cornell) share 1 hospital New York-Presbyterian </li></ul>
    8. 8. Goals for Clinical Research Center <ul><li>Continue to provide both inpatient and outpatient space and dedicated personnel for patient-oriented research. </li></ul><ul><li>Expand support for patient oriented research beyond the confines of the Clinical Research Center (CRC). </li></ul><ul><li>Partner with the Community Engagement Resource (CER) to enhance off-site research. </li></ul>
    9. 9. Implementation and Oversight: Changing the Culture <ul><li>CUMC 2006: 807 new protocols, 1563 renewals </li></ul><ul><li>Pilot survey of inpatient units (Neurology and Pediatric Oncology) </li></ul><ul><li>Collaboration between CRC, hospital and School of Nursing to assess staff knowledge, develop and implement research curriculum for nurses, PAs, MDs. </li></ul><ul><li>Develop a mechanism to Identify participants in research protocols. </li></ul>
    10. 10. Implementation and Oversight: Research in the ICUs and Emergency Departments <ul><li>New York State has no statute or regulation that clearly identifies a legally authorized representative, and no case law that resolves the issue. </li></ul><ul><li>This situation prevents research in critical care units and Emergency Departments. </li></ul><ul><li>18 clinical trials unable to enroll any patients or where enrollment was reduced by 50%. </li></ul><ul><li>In collaboration with Dean’s office and University Counsel, we have documented need for change in the New York State Legally Authorized Representative law. </li></ul>
    11. 11. Regulatory Knowledge Support And Ethics Resource <ul><li>Education/Training </li></ul><ul><ul><li>Revised Good Clinical Practice requirement – awaiting institutional approval </li></ul></ul><ul><ul><li>Bimonthly workshops on regulatory and ethical issues – growing attendance </li></ul></ul><ul><ul><li>Research staff and investigators have had little training in legal/ethical theory of informed consent </li></ul></ul><ul><ul><li>Provide IRB/HIPAA training </li></ul></ul><ul><ul><ul><li>basic (2 hr), advanced (6 wks) – tracking results </li></ul></ul></ul><ul><ul><ul><li>Department-specific presentations </li></ul></ul></ul>
    12. 12. Adult ED: Research Participation Current Investigators 3/13 (23.1%) MDs 1/22 (4.5%) nurses 0/8 (0%) EMS Past Investigators 8/13 (61.5%) MDs 3/22 (13.6%) nurses 1/8 (12.5%) EMS
    13. 13. HIPPA (Research) Certification ½ No Certification in HIPPA for Research 6/13 (46.2%) physicians 19/22 (86.4%) nurses 7/8 (87.5%) EMS
    14. 14. Challenges <ul><li>What level of protocol review and data safety monitoring is required for CTSA protocols? </li></ul><ul><li>What is the most efficient means to educate MDs, nurses, health professionals and participants? </li></ul><ul><li>How do we develop a process to permit clinically important research with adults who lack decisional capacity in NY? </li></ul>

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