Southeast Cancer Control Spring Meeting

1. Southeast Cancer Control Spring Meeting Friday, April 30, 2010 8:30am Grandover Resort Conference Center Greensboro, NC James N. Atkins, MD Principal Investigator Judith O. Hopkins, MD Co-Principal Investigator A Community Clinical Oncology Program (CCOP) Funded by The National Cancer Institute (NCI)

2. New SCCC Members since October 2009 Allen, David, MO, Pinehurst Barrett II, Rolland, GYN-O, Winston-Salem Bryan, Charles, MO, Asheville Burgess, Earle, MO, Charlotte (CMC) Chen, Franklin, MO, Winston-Salem Cook, David, UR, Winston-Salem Evans, Aubrey, UR, Winston-Salem Fisher, Julie, MO, Charlotte (Presbyterian) Haggstrom, Daniel, Charlotte (CMC) Hall, Craig, UR, High Point Hubbard, Jeremy, UR, Winston-Salem Hudson, Jon, UR, Winston-Salem Huff, Jason, MO, High Point Konefal John, RO, Charlotte (Presbyterian) Lewis, Grant, MO, Savannah

3. New SCCC Members Since October 2009 Meeting Mileham, Kathryn, MO, Charlotte (CMC) Mitchell, Sandra, RO, Greensboro Moose, Dawn, RO, Winston-Salem Nakhoul, Ibrahim, MO, Kingsport, TN Nycum, Lawrence, GYN-O, Winston-Salem Owens, Kristi, RT, Hendersonville Patel, Sushma, RO, Pinehurst *Plunkett, Steven, RO, Charlotte (Presbyterian) Roof, Kevin, RO, Charlotte (Presbyterian) Saylors, Gene, MO, Charleston Sears, Judith, RO, Winston-Salem Slatkoff, Marc, MO, Winston-Salem Warlick, William, RO, Charlotte (Presbyterian) * reinstated

4. Fall SCCC/POA Meeting August 26 - 28, 2010Grove Park Inn, Asheville, NC

5. Deborah Watkins Bruner, RN, PhD, FAAN “New Frameworks for RTOG CCOP Research”

6. SCCC Accrual Credits Year 23 (6/1/09 – 2/28/10) Restricted Funds of $ 240k will be released because our accruals/credits are projected to exceed NCI’s assigned RX and CC quotas by as much as 100 credits each.

9. Year 23 Total Accruals by Research Base

10. SCCC Community Accruals Yr 23 Projection/Actual (6/1/09 – 2/28/10)

11. SCCC Community Accruals Yr 23 Projection/Actual vs. (6/1/09 – 2/28/10)

12. MD Rx Accruals Year 23 (6/1/09 – 2/28/10)

13. MD CC Accruals Year 23 (6/1/09 – 2/28/10)

14. Exceptional CCOP!! Five-Year Competing Renewal Application June 1, 2010 - May 31, 2015 SCCC received a Priority Score of 18 10 Exceptional: Exceptionally strong with essentially no weakness 20 Outstanding: Extremely strong with negligible weaknesses

15. Strengths from Summary of Discussion Quotes • Highly ranked in terms of accrual with many research bases • Catchment area provides impressive access to patient population for adequate accrual to RX and CC trials • Dr. Atkins – CCOP PI since 1993; demonstrates ability to accrual patients • Stable CCOP structure with demonstrated success continued

16. Strengths from Summary of Discussion Quotes • Extensive contribution to research bases by PI • “Community Leader” infrastructure at each component provides an overarching stability that appears very strong • Excellent (phenomenal) recruitment record that continues to grow • Strong program, difficult to make major improvements

17. Strengths from Critiques • Outstanding application • Outstanding accrual with excellent menu of protocols • Supportive central office (SCCC Operations Office) – 120 years experience among 5 individuals • Outstanding minority accrual • Good organizational management (continued)

18. Strengths from Critiques • Large multi-state catchment area with over 8 million residents – impressive access • Services 60 counties in 5 states (GA, NC, SC, TN, VA) • Consistently meets or exceeds funded accrual quotas • Physician commitment of a minimum of two patient accruals/year continued

19. Strengths from Critiques • Experienced Co-PI is identified and is qualified • Training and communication between component and • office staff is well developed and occurs at regular intervals • One of top accruers in all research bases that leads to a • dramatic impact on moving science forward • Demonstrates great ability to impact national studies with • differing demographics – may not be represented if not for • membership in SCCC • Received grant money to conduct media campaign to • increase accrual at several components – very innovative • approaches to educating community

20. Summary of 5 Year SCCC Accruals

21. NCI Credit Quota vs SCCC Actual Credits

22. SCCC Accrual by Research Bases (RX + CC)

23. SCCC RX & CC MD Accruals for Past Three Years

24. Weaknesses from Summary of Discussion • Minimum of 2 accruals/year/physician does not appear to be • enforced • Why recruitment plan for SWOG S0702 “A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment” was not implemented after opening the study (activation 12/15/08) • Anticipated enrollment is 72 subjects: Current enrollment • is 6 (Asheville, Goldsboro, Savannah, Winston-Salem) • Additional components with study open: Hendersonville, • Kingsport, Presbyterian, Statesville

25. Weaknesses from Critiques • Internal audits occur mainly as pre-audits prior to external audits • Follow-up credits (STAR & SELECT)are significant portion • (62.4%) of cancer control credits • Number of MDs place small number of patients on trial • CALGB and NSABP audits have higher number of • unacceptable ratings • NCI award for Public Awareness Campaign appears to be met • with mixed success. Evaluation of brochures has not been • implemented satisfactorily since less than 1% of surveys • returned from patients (missed opportunity). Increased • funding did not produce anticipated increase in accruals.