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CCOP, MBCCOP

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    CCOP, MBCCOP CCOP, MBCCOP Presentation Transcript

    • CCOP, MBCCOP & Research Base Meeting Lori Minasian, MD Chief, Community Oncology & Prevention Trials Research Group Division of Cancer Prevention
      • Meeting Objectives
      • Information and Updates
        • Grant Related Issues
        • Program Related Issues
        • Clinical Trials Related Issues
      • Feedback on Issues
      • Format for Discussion
      Community Clinical Oncology Program
      • Grant Topics
      • Electronic Grant Submission
      • Interpreting Notice of Award (NoA)
      • Completing Financial Status Report (FSR)
      • Peer Review Process
      Community Clinical Oncology Program
      • Program Topics
      • New CCOP Database
        • Submission of Organizational Changes
        • Submission of Accrual Tables
      • Evaluation Efforts
      • Breakout Sessions
        • Meant to Foster Constructive Discussion
        • Research Base PIs/Administrators meeting
        • Minority Recruitment Session
      Community Clinical Oncology Program
      • Clinical Trials Topics
      • CTSU Updates
        • CTSU Site Advisory Panel
        • Update on NCI’s CIRB
      • CMS Clinical Trials Policy
      • Update on CTWG Initiatives
      Community Clinical Oncology Program
    • State of the CCOP Program Community Clinical Oncology Program
    • Rumors…. … . About the CCOP Program’s demise have been greatly exaggerated. Community Clinical Oncology Program
    • CCOP & MBCCOP Request for Applications (RFA) Community Clinical Oncology Program
      • CCOP & MBCCOP RFA for FY 2008
      • Applications Received July 2007
      • Peer Review Scheduled in November 2007
      • Second Level Review to NCAB February 2008
      • Awards in June 2008
      Community Clinical Oncology Program
      • CCOP & MBCCOP RFA for FY 2009
      • Early Start to the Process This Year
        • Significant Support By the Board of Scientific Advisors (BSA) for the CCOP/MB-CCOP RFAs
      • Anticipate Early Spring 2008 Release
      • Submission Process Still Paper-based (i.e., Not yet Electronic )
      Community Clinical Oncology Program
      • CCOP & MBCCOP RFA for FY 2009
      • Submission of application requires grantee institution & PI to be registered with NIH eRA Commons
      • Session on Peer Review
        • CCOP & MB-CCOP RFA Peer Review Panels & Lessons Learned
      Community Clinical Oncology Program
    • Statistics for the CCOP Program Community Clinical Oncology Program
    • Funded CCOP Programs in FY 2007 Headquarters in 10 States Research Bases 13 10 States, DC & Puerto Rico MBCCOPS 14 29 States CCOPS 49
      • Update on Program Funding in FY 2007
      • Newly funded
        • Sacred Heart MBCCOP, Mobile, AL
        • LSUHSC-Shreveport, Shreveport, LA
        • Suny Downstate Medical Center, Brooklyn, NY
      • No longer funded
        • Northern New Jersey CCOP
        • Our Lady of Mercy MBCCOP
        • University of Michigan Research Base
      Community Clinical Oncology Program
      • Welcome to the new MBCCOP PIs
      • Dr. Paul Schwarzenberger
        • Sacred Heart Health System
      • Dr. Glen Mills
        • LSUHSC-Shreveport
      • Dr. William Solomon
        • Suny Downstate Medical Center
      Community Clinical Oncology Program
      • Participating Physicians (3,565)
        • 2,385 Physicians Accrue Trial Participants
        • 1,180 Physicians Refer Trial Participants
      • Participating Hospitals (405)
      Community Clinical Oncology Program
    • Community Clinical Oncology Program
    • Community Clinical Oncology Program
      • FY 2007 Notice of Grant Award
        • Base Budget with Accrual Expectations
        • Restricted Treatment Supplements to CCOP/MBCCOP
        • Restricted Cancer Control (Prevention Supplements) to CCOP/MB-CCOP
      Community Clinical Oncology Program
    • CCOP Organizational Changes Community Clinical Oncology Program
      • CCOP Organizational Changes
      • i.e., adding/deleting physicians, affiliates/components & research bases
      • Paper-based process for past 20+ years
      Community Clinical Oncology Program
      • Organizational Changes
      • New web-based database developed to Process Organizational Changes Electronically
      • New Process more Efficient & Transparent
      • Implement in a Step-Wise Fashion
        • Physicians
        • Affiliates/Components
        • Accrual Tables for 6, 9, & 12 month Data
        • Research Bases
      Community Clinical Oncology Program
    • Cancer Control Trials Community Clinical Oncology Program
      • CCOP Cancer Control Trials
        • Cancer Control Includes
          • Cancer Prevention
            • Chemoprevention
            • Surgical Intervention
            • Smoking Cessation
          • Symptom Management Trials
          • Continuing Care
          • Survivorship
          • Quality of Life
          • Other
      Community Clinical Oncology Program
    • Phase III Treatment Trials with HRQOL Endpoints 39 28 TOTAL # TRIALS: 7 5 PROSTATE 1 0 MELANOMA 4 4 LUNG 4 4 HEMATOLOGIC 2 2 HEAD & NECK 4 2 GYNECOLOGIC 5 2 COLORECTAL 6 4 CNS 6 5 BREAST
    • Symptoms Under Study in Trials Since 1995 5 Neuropathy 2 Skin Toxicities 10 Anorexia & Weight Loss 7 Mucositis 7 Quality of Life 6 Diarrhea 28 Others ( e.g., Ascites, Depression, HRT, Sexual Functioning, Stress & Distress, etc…) 1 Hand & Foot Syndrome 5 Prevention of Weight Loss 5 Infection 6 Osteoporosis 8 Cognitive Function 9 Nausea & Vomiting 11 Hot Flashes 12 Pain 12 Fatigue Number of Studies Symptoms
    • Number of Newly Activated and Active CCOP’S Symptom Management Trials from CY 1995 to 2006 186 11 4 1996 122 8 2 1995 2214 31 12 2001 860 26 10 2000 1835 27 7 1999 1046 22 10 1998 577 14 3 1997 3498 61 19 2006 61 59 45 46 Total Active Trials 3437 3300 3824 3139 Accrual 9 2005 18 2004 18 2003 17 2002 Newly Activated Trials Calendar Year
    • Clinical Trials Working Group (CTWG) Community Clinical Oncology Program
      • NCI’s Coordinating Center for Clinical Trials (CCCT)
      • Budget to Fund Specific CTWG initiatives
        • High Accruing Site Incentives
        • Incentives to Increase Minority Accrual
        • Correlative Sciences
      Community Clinical Oncology Program
      • CCCT High Accruing Site Incentive Awards
      • FY 2007 Budget - $5 million
      • ¼ of Funds Allocated to CCOP Program
      • Awarded to 10 Highest Accruing (treatment) CCOPS
      • ¾ of Funds Awarded to Cooperative Groups
          • For High Accruing Member Sites
      Community Clinical Oncology Program
      • CCCT High Accruing Site Incentive Awards
      Community Clinical Oncology Program Northern Indiana Cancer Research Consort. Robin T. Zon, MD Missouri Valley Cancer Consort. Gamini Soori, MD Michigan Cancer Research Consort. Philip J. Stella, MD Carle Cancer Center Kendrith M. Rowland, MD Illinois Oncology Research Assoc. John W. Kugler, MD Columbus J. Philip Kuebler, MD Christiana Care Stephen Grubbs, MD Metro-Minnesota Patrick J. Flynn, MD Wichita Shaker R. Dakhil, MD Southeast Cancer Control Consort. James N. Atkins, MD CCOP Principal Investigator
      • NCI’s Coordinating Center for Clinical Trials (CCCT)
      • Has a budget to fund specific CTWG initiatives
        • High Accruing Site Incentives
        • Incentives to Increase Minority Accrual
        • Correlative Sciences
      Community Clinical Oncology Program
      • CCCT Enhanced Minority Recruitment Awards
      Community Clinical Oncology Program Stroger Hospital of Cook County MBCCOP Howard A. Zaren, MD Meharry Medical College MB-CCOP Steven N. Wolff, MD Virginia Commonwealth Univ. MBCCOP John D. Roberts, MD Warren Cancer Research Foundation CCOP James B. Lockhart, MD South Texas Pediatric MB-CCOP Ann-Marie Langevin, MD Medical College of Georgia MB-CCOP Anand P. Jillella, MD Boston Medical College Karen Freund, MD MBCCOP/CCOP/Non-CCOP Principal Investigator
    • ? QUESTIONS ? Community Clinical Oncology Program