CCOP, MBCCOP

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CCOP, MBCCOP

  1. 1. CCOP, MBCCOP &CCOP, MBCCOP & Research Base MeetingResearch Base Meeting Lori Minasian, MDLori Minasian, MD Chief, Community OncologyChief, Community Oncology & Prevention Trials Research Group& Prevention Trials Research Group Division of Cancer PreventionDivision of Cancer Prevention
  2. 2. 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
  3. 3. Grant Topics ● Electronic Grant Submission ● Interpreting Notice of Award (NoA) ● Completing Financial Status Report (FSR) ● Peer Review Process Community Clinical Oncology Program
  4. 4. 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
  5. 5. 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
  6. 6. State of the CCOP Program Community Clinical Oncology Program
  7. 7. Rumors…. ….About the CCOP Program’s demise have been greatly exaggerated. Community Clinical Oncology Program
  8. 8. CCOP & MBCCOP Request for Applications (RFA) Community Clinical Oncology Program
  9. 9. 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
  10. 10. 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
  11. 11. 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
  12. 12. Statistics for the CCOP Program Community Clinical Oncology Program
  13. 13. Funded CCOP Programs in FY 2007 49 CCOPS 29 States 14 MBCCOPS 10 States, DC & Puerto Rico 13 Research Bases Headquarters in 10 States
  14. 14. 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 Community Clinical Oncology Program
  15. 15. 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
  16. 16. Participating Physicians (3,565) 2,385 Physicians Accrue Trial Participants 1,180 Physicians Refer Trial Participants Participating Hospitals (405) Community Clinical Oncology Program
  17. 17. 0 1 2 3 4 5 6 7 8 9 10 11 12 2000 2001 2002 2003 2004 2005 2006 2007 Est CREDI TS Thousands Treat ment Cancer Cont rol Community Clinical Oncology Program
  18. 18. Funding Levels $0 $10 $20 $30 $40 $50 2000 2001 2002 2003 2004 2005 2006 2007 Fiscal Year Millions CCOP MB-CCOP Community Clinical Oncology Program
  19. 19. 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
  20. 20. CCOP Organizational Changes Community Clinical Oncology Program
  21. 21. CCOP Organizational Changes i.e., adding/deleting physicians, affiliates/components & research bases ● Paper-based process for past 20+ years Community Clinical Oncology Program
  22. 22. 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
  23. 23. Cancer Control Trials Community Clinical Oncology Program
  24. 24. 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
  25. 25. Phase III Treatment Trials with HRQOL Endpoints BREAST 5 6 CNS 4 6 COLORECTAL 2 5 GYNECOLOGIC 2 4 HEAD & NECK 2 2 HEMATOLOGIC 4 4 LUNG 4 4 MELANOMA 0 1 PROSTATE 5 7 TOTAL # TRIALS: 28 39
  26. 26. Symptoms Under Study in Trials Since 1995 Symptoms Number of Studies Fatigue 12 Pain 12 Hot Flashes 11 Anorexia & Weight Loss 10 Nausea & Vomiting 9 Cognitive Function 8 Mucositis 7 Quality of Life 7 Diarrhea 6 Osteoporosis 6 Infection 5 Prevention of Weight Loss 5 Neuropathy 5 Skin Toxicities 2 Hand & Foot Syndrome 1 Others (e.g., Ascites, Depression, HRT, Sexual Functioning, Stress & Distress, etc…) 28
  27. 27. Calendar Year Newly Activated Trials Total Active Trials Accrual 1995 2 8 122 1996 4 11 186 1997 3 14 577 1998 10 22 1046 1999 7 27 1835 2000 10 26 860 2001 12 31 2214 2002 17 46 3139 2003 18 45 3824 2004 18 59 3300 2005 9 61 3437 2006 19 61 3498 Number of Newly Activated and Active CCOP’S Symptom Management Trials from CY 1995 to 2006
  28. 28. Clinical Trials Working Group (CTWG) Community Clinical Oncology Program
  29. 29. 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
  30. 30. 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
  31. 31. CCCT High Accruing Site Incentive AwardsPrincipal Investigator CCOP James N. Atkins, MD Southeast Cancer Control Consort. Shaker R. Dakhil, MD Wichita Patrick J. Flynn, MD Metro-Minnesota Stephen Grubbs, MD Christiana Care J. Philip Kuebler, MD Columbus John W. Kugler, MD Illinois Oncology Research Assoc. Kendrith M. Rowland, MD Carle Cancer Center Philip J. Stella, MD Michigan Cancer Research Consort. Gamini Soori, MD Missouri Valley Cancer Consort. Robin T. Zon, MD Northern Indiana Cancer Research Consort. Community Clinical Oncology Program
  32. 32. 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
  33. 33. CCCT Enhanced Minority Recruitment AwardsPrincipal Investigator MBCCOP/CCOP/Non-CCOP Karen Freund, MD Boston Medical College Anand P. Jillella, MD Medical College of Georgia MB- CCOP Ann-Marie Langevin, MD South Texas Pediatric MB-CCOP James B. Lockhart, MD Warren Cancer Research Foundation CCOP John D. Roberts, MD Virginia Commonwealth Univ. MBCCOP Steven N. Wolff, MD Meharry Medical College MB-CCOP Community Clinical Oncology Program
  34. 34. ? QUESTIONS ? Community Clinical Oncology Program

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