1. 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

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 Department of Health & Human Services National Institutes of Health National Cancer Institute Division of Cancer Prevention Community Oncology Prevention Trials Research Group Community Clinical Oncology Program

10. Department of Health & Human Services

11. National Institutes of Health - Institutes Institute NameAcronym Year Established National Cancer InstituteNCI1937 National Institute of Dental & Craniofacial ResearchNIDCR1948 National Heart, Lung & Blood InstituteNHLBI1948 National Institute of Mental HealthNIMH1949 National Institute of Diabetes & Digestive & Kidney DiseasesNIDDK1950 National Institute of Neurological Disorders & StrokeNINDS1950 National Library of MedicineNLM1956 National Institute of General Medical SciencesNIGMS1962 Eunice Kennedy Shriver National Institute of Child Health & Human DevelopmentNICHD1962 National Eye InstituteNEI1968 National Institute of Environmental Health SciencesNIEHS1969 National Institute on Alcohol Abuse & AlcoholismNIAAA1970 National Institute on Drug AbuseNIDA1973 National Institute on AgingNIA1974 National Institute of Arthritis & Musculoskeletal & Skin DisordersNIAMS1986 National Institute of Nursing ResearchNINR1986 National Institute on Deafness & Other Communication DisordersNIDCD1988 National Human Genome Research InstituteNHGRI1989 National Institute of Biomedical Imaging & BioengineeringNIBIB2000 National Institute on Minority Health & Health DisparitiesNIMHD2010

12. National Institutes of Health – Centers Center NameAcronym Clinical CenterCC Fogarty International CenterFIC National Center for Complimentary & Alternative MedicineNCCAM National Center for Research ResourcesNCRR Center for Information TechnologyCIT Center for Scientific ReviewCSR

13. NIH Clinical Center Bethesda, Maryland

14. National Cancer Institute - Intramural National Cancer Institute Center for Cancer Research CCR: Branch, Lab & Program Index Division of Cancer Epidemiology and Genetics DCEG Research Interests

15. National Cancer Institute - Extramural National Cancer Institute Division of Cancer Prevention Division of Cancer Control & Population Sciences Division of Cancer Biology Division of Cancer Treatment & Diagnosis Division of Extramural Activities

16. National Cancer Institute 6130 Executive Blvd, Rockville, MD

17. National Cancer Institute Division of Cancer Treatment & Diagnosis Division of Cancer Treatment & Diagnosis Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Biometrics Research Branch Translational Research Program Office of Cancer Complementary & Alternative Medicine

18. National Cancer Institute DCTD - CTEP Division of Cancer Treatment & Diagnosis Cancer Therapy Evaluation Program Clinical Grants & Contracts Branch Clinical Investigations Branch Clinical Trials Monitoring Branch Investigational Drug Branch Operations & Informatics Branch Pharmaceutical Management Branch

19. National Cancer Institute Division of Cancer Prevention Division of Cancer Prevention Research Groups Basic Prevention Science BiometryCancer Biomarkers Chemopreventive Agent Development Community Oncology & Prevention Trials Early DetectionNutritional Science

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 1.Incorporate emerging science & novel trial designs into cancer prevention/control research 2.Maximize community resources 3.Use epidemiological and biological data from underrepresented populations to address disparate clinical outcomes 4.Improve trial access and participation 5.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)