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Southeast Cancer Control Fall Meeting

Southeast Cancer Control Fall Meeting. The Omni Hotel Hilton Head, SC Friday, October 4, 2013 7:00 am ( breakfast buffet provided ) James N. Atkins, MD Principal Investigator Judith O. Hopkins, MD Co-Principal Investigator.

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Southeast Cancer Control Fall Meeting

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  1. Southeast Cancer Control Fall Meeting The Omni Hotel Hilton Head, SC Friday, October 4, 2013 7:00 am (breakfast buffet provided) 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 Physicians • Asheville, NC Praveen Vashist, MD - Med Onc • Charlotte, NC: Matthew J. McDonald, MD – GynOnc Kellie E. Schneider, MD – GynOnc • Danville, VA Qiwei W. Gai, MD – Med Onc (new Community Leader)

  3. Florence, SC • Rommel Lu, MD – Med Onc • Greensboro, NC • Eric S. Neijstrom, MD – Med Onc (re-instatement) • Pinehurst, NC • John W. Bryon, MD – GynOnc (re-instatement) • Michael J. Sundborg, MD – GynOnc • Savannah, GA • Michael D. Hasselle, MD - Rad Onc

  4. New SCCC Component Bon Secours Virginia Health System Richmond, VA Community Leader: William J. Irvin, Jr., MD Study Coordinator: Marie Johnson, RN, BSN • Physicians: • Ryan S. Raddin, MD • Steven M. Duffy, MD (present today) • Susan W. Schaffer, MD Membership approval June 1, 2013

  5. New Community Leader Danville, VA: Community Leader ­QiweiW. Gai, MD

  6. Component Resignation Due to regulatory obstacles and issues, Johnson City, TN (Mountain States Health Alliance) has resigned from SCCC as of 5/31/13

  7. New Consent Template Implementation • Several research base studies have begun the new template features • Changes are occurring in the “Risks” section of some consent forms http://ctep.cancer.gov/protocolDevelopment/ default.htm

  8. Upcoming Research Base Audit NSABP – February 2014 Treatment and Industry To be conducted at SCCC Operations Office pending component accruals

  9. PIDC Download Capabilities • The SCCC website now has the feature for MDs and research staff to download the PIDC onto iPhones, iPadsor laptops as a PDF. The PIDC can be streamlined to be specific to your component. • If you have questions, concerns or issues, please contact Kim Fulton @ kfulton@wakehealth.edu • Webmaster may need to be contacted if Kim cannot resolve issue or concern

  10. New PIDC Format • As of April 1, 2013, new format design • Symptom Management replaces general Cancer ControlSection • Cancer Controlfor each disease site is listed with the disease heading as applicable • Treatment for each disease site is listed after the Cancer ControlSection

  11. Back Links…coming soon The benefits are: • Back links are links between your site and the clinical trials you have open with SCCC • Increased awareness of SCCC and their affiliation with ClinicalTrials • Easier for patients to find available trialsand gather information for themselves • Available trials are always current with the SCCC website, eliminating the need of Components to list trials on their website

  12. SCCC Accrual Credits Year 26 (6/1/12 – 5/31/13) No restricted funds were provided.

  13. Year 26 Accrual by Research Base

  14. Top Accruing MDs 6/1/12-5/31/13

  15. NCI Recognition for High Accruals Silver Award James N. Atkins, MD (Goldsboro) Judith O. Hopkins, MD (Winston-Salem) 15-19 Credits for 9 months (6/1/12-2/28/13)

  16. SCCC Accruals per Component for Year 26 (6/1/12-5/31/13)

  17. SCCC Accrual Credits Year 27 – First Quarter (6/1/13 – 8/31/13) Restricted funds will be released if SCCC exceeds NCI quota by 40 credits

  18. Top Accruing MDs - First Quarter 6/1/13-8/31/13

  19. SCCC Accruals per Component for First Quarter (6/1/13-8/31/13)

  20. NCI National Clinical Trials Network (NCTN) Effective March 1, 2014 Seven Research Bases will be funded: 4 Adult Cooperative Groups Alliance ECOG/ACRIN NRG SWOG 1 Pediatric Cooperative Group COG 2 Cancer Control Groups from existing 4 CCCWFU URCC SunCoast MD Anderson

  21. NCTN Guidelines • Mandate use of NCI CIRB by CMS and NCTN for all NCORP sites • CIRB will have 2 CIRBs • One for Phase III trials (existing CIRB) • Second for Phase II (early phase) trials (to begin functioning this year) Dr. James Bearden from Upstate CCOP in Spartanburg, SC will be serving on the Phase II CIRB

  22. NCTN Guidelines • All member institutions/sites must have appropriate and accurate NCI institutional codes (Performance Sites Codes or CTEP ID #s) approved by NCI • All treating facilities will be required to have Site Codes – includes all clinics, satellites, etc. where patients are being treated (no site will be allowed to utilize the same site code as another treating site)

  23. NCTN Guidelines Only one mechanism will be allowed for access to clinical trials Options of Access 1. Main Member 2. CCOP There can only be one parent with children; thus, NO “blended” families

  24. Current System Scenario • A single institution (i.e., Hospital, academic center, etc.) may be enrolling patients onto cooperative group trials as a member institution for one or multiple cooperative groups but also as a member of a CCOP or MBCCOP for one or multiple other (i.e., COG or GOG) cooperative groups, i.e., “swimming in multiple swim lanes”.

  25. NCI’s Community Oncology Research Program (NCORP) Information based on NCI presentation on 9/20/13 Funding Opportunity Announcement (FOA) due to be released in the early fall (hopefully by mid-October) Application Deadline will be either December 2013 or January 2014 Awards of NCORP sites will be early fall 2014 FOA will NOT be released again until 2018

  26. NCORP • Proposed number of NCORPS • Up to 40 NCORP General sites • Up to 14 minority/underserved NCORP sites (30% minority population • Minimum of 80 credit accruals/year (divided equally between treatment and cancer control, i.e., 40 for RX and 40 for CC) • Must be able to conduct Cancer Care Delivery Research

  27. NCORP Funding • Based on historical accruals • Sites with history of >200 accrual credits/year will receive extra funding but increased funding will not begin until registration # 201 • No credits will be given to CCDR participation • All funding will be upfront – NO funding for follow-up

  28. Cancer Care Delivery Research (CCDR) • Involves (not inclusive list): • Patient navigators • Biospecimens • Genomics • Multi-disciplinary care plans • Disparities • Patient Care Coordination • Palliative and Supportive Care

  29. NCORP • SCCC will apply for NCORP application • Long history of exceeding accrual goals • Excellent relationship with NCI • Largest CCOP in the United States with • 18 components are currently participating • 194 physician members • 110 research nurses/associates

  30. NCORP Plans Merge with Upstate CCOP in Spartanburg, SC (Upstate has joined us today as guests) • PI: James Bearden, MD • Administrator: Leesa Judd, RN, CCRC, CIP • NCCCP Coordinator: Lucy Gansauer, RN, MSN, OCN CCOP since 1983 and long history of successful accruals Funded as an NCI Community Cancer Centers Program (NCCCP) since 2008 – has experience with Cancer Care Delivery Research

  31. Other CCOP Mergers • SCCC has talked with other CCOPs – one did not wish to merge and one other is still considering the possibility • CCOPs across the US are merging to submit the NCORP FOA; therefore, there will be multiple “regional” CCOPs applying for NCORP

  32. NCORP Potential Applicants • 49 Existing CCOPs across US • 17 Existing Minority-Based CCOPs across US • NCI Community Cancer Center Programs (NCCCP) – approx. 31 funded at one time • Catholic Health Initiative – hospitals across US • Individual institutions/medical centers with track record for clinical trials and infrastructure for program

  33. SCCC Spring Meeting 2014 Information coming soon…

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