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CCOP, MBCCOP & Research Base Meeting Lori Minasian, MD Chief, Community Oncology & Prevention Trials Research Group Division of Cancer Prevention. Community Clinical Oncology Program. Meeting Objectives Information and Updates Grant Related Issues Program Related Issues
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CCOP, MBCCOP & Research Base Meeting Lori Minasian, MD Chief, Community Oncology & Prevention Trials Research Group Division of Cancer Prevention
Community Clinical Oncology Program 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 requiresgrantee 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 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 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-baseddatabase 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
Number of Newly Activated and Active CCOP’S Symptom Management Trials from CY 1995 to 2006
Community Clinical Oncology Program 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 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 ? QUESTIONS ?