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Objectives

A New Point of View: An “Outsider’s” Perspective From the Inside of the NCI and the CCOP Strategic Plan Marge Good, RN, BSN, MPH, OCN MD Anderson Cancer Center Meeting March 3, 2011. Objectives. Background/History Current role Learning the NCI from the inside

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Objectives

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  1. A New Point of View: An “Outsider’s” Perspective From the Inside of the NCI and the CCOP Strategic PlanMarge Good, RN, BSN, MPH, OCNMD Anderson Cancer Center MeetingMarch 3, 2011

  2. Objectives • Background/History • Current role • Learning the NCI from the inside • CCOP Strategic Plan overview & highlights

  3. Background/History • Began working in oncology 1983 • Delivered chemotherapy • Ordered drugs • Phone triage nurse • Hired as CCOP research nurse in 1988 • Enrolled patients on clinical trials • Collected and submitted data • Typed flow sheets () • Began with 3 nurses, 2 office staff & Director

  4. Background/History • 1993 began role as Administrative Director • Reviewed newly activated trials for possible implementation • Prepared selected trials for IRB submission • Devised systems and processes for study implementation • Maintained communication between research bases and CCOP • Managed CCOP staff (25 nurses, CRAs) • Monitored accrual, data submission timeliness, queries, internal audit findings & staff workload on monthly basis • Prepared and submitted NCI Progress Report & NIH/NCI CCOP U10 re-competing grant applications • Communicated with PI and sub-investigators • Coordinated communication and training for satellite sites • Participated in fiscal agent oncology service line activities • Developed SOPs • Monitored budget

  5. Background/History • 28 years of oncology experience • 22 years total with Wichita CCOP • 17 years as Administrative Director – Wichita CCOP

  6. Current Role • Nurse Consultant – COPTRG/DCP/NCI • Collaborate and consult with CCOPs as a representative of the NCI • Provide leadership, development and coordination for activities focusing on clinical trial management, accrual and outreach to minority populations • Develop and/or assist in the development of clinical trial related position statements, public relations documents, guidelines and other materials • Organize, coordinate and conduct meetings as well as serve on advisory, steering and planning committees and other groups to address clinical trials in community setting and related issues • Lead efforts to increase accrual, address barriers and evaluate strategies • Mentor new clinical trial sites and contribute to the evaluation of the community clinical trials program

  7. Current Role • Major role: • Bring community perspective to the NCI • Years of experience • One CCOPs perspective • No longer physically in the community • Not the expert for all CCOPs • Each are different in their own ways • Communication will be key

  8. How Things Work: A View From the Inside • It is the government! • Many layers • Institutes, divisions, branches, groups • Each with goals, grant programs and funding • Complex reporting structure • Security is tight!! • Still much to learn

  9. A Visual Perspective

  10. Department of Health & Human Services

  11. National Institutes of Health - Institutes

  12. National Institutes of Health – Centers

  13. NIH Clinical CenterBethesda, Maryland

  14. National Cancer Institute - Intramural

  15. National Cancer Institute - Extramural

  16. National Cancer Institute6130 Executive Blvd, Rockville, MD

  17. National Cancer InstituteDivision of Cancer Treatment & Diagnosis

  18. National Cancer InstituteDCTD - CTEP

  19. National Cancer Institute Division of Cancer Prevention

  20. Entrance

  21. COPTRG

  22. CCOP Strategic Plan • Established to explore issues needing to be addressed to ensure programs continue to successfully contribute to the NCI mission. • In person meeting and conference calls

  23. Strategic Goals • Incorporate emerging science & novel trial designs into cancer prevention/control research • Maximize community resources • Use epidemiological and biological data from underrepresented populations to address disparate clinical outcomes • Improve trial access and participation • Build on success of CCOP/MBCCOP to further improve the ability of community institutions to accrue to clinical trials.

  24. 1. Incorporate emerging science & novel trial designs into cancer prevention/control research • Develop and enhance survivorship research • Enhance research on acute treatment toxicities & cancer symptoms • Foster research on risk assessment and risk modeling • Develop funding mechanisms for correlative studies • Foster relationships with basic science researchers • Develop mechanisms to encourage training for young & mid-career cancer prevention & control investigators

  25. 2. Maximize community resources • Develop supplemental funding for biospecimen collection • Develop new funding model to support true level of effort • Encourage standardization & improve efficiency across Network • Develop process to address issues related to changing health care environment • Provide support to professional organizations to develop mentorship programs • Foster collaboration with NCI Office of Communication & Education • Address partial overlap of activities with other NCI community programs

  26. 3. Use epidemiological and biological data from underrepresented populations to address disparate clinical outcomes • Apply current & emerging science to identify & address research questions • Develop trans-disciplinary working group to develop pilot studies • Promote cancer risk assessment or individuals in underserved communities

  27. 4. Improve trial access and participation • Consider broadening eligibility requirements for MBCCOPs • Facilitate language translation • Implement a plan for assigning credit for screening • Develop recommendations/guidelines for publications • Review accrual requirements for MBCCOPs • Develop an effective model to incorporate patient navigation • Increase diversity in the workforce

  28. 5. Build on success of CCOP/MBCCOP to further improve the ability of community institutions to accrue to clinical trials • Develop Best Practice Accrual Guidelines • Systematically collect & maximize use of data in CCOP progress reports on patients screened • Develop process to rapidly indentify & address slow accruing clinical trials • Encourage development of correlative studies that address accrual

  29. My Strategic Plan-Related Tasks • CCOP 101 Manual • Accrual Best Practices Guidelines • Develop web-based training modules for CCOP staff • Improve the auditing process • Establish consistent means of communication between CCOPs and NCI • To listen and help decrease barriers • Provide input for new funding structure • Other tasks as needed

  30. Future of CCOP • Strategic Plan development and past successes assured favorable review by BSA • Viewed as an important program by the NCI Director • Provided approval for 3 years of funding • Continued success and viability will be further ensured by implementation of strategic plan action items • Will require involvement of CCOP leaders (PIs, Administrators, RBs & COPTRG)

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