1. 1 NCORP Overview November 2013 NCORP Director Worta McCaskill-Stevens, MD, MS Chief, Community Oncology and Prevention Trials Research Group Division of Cancer Prevention NCORP Associate Director Steven Clauser, PhD Chief, Outcomes Research Branch Division of Cancer Control & Population Sciences In Collaboration with the NCI Division of Cancer Treatment and Diagnosis and the NCI Center to Reduce Cancer Health Disparities

2. 2 BACKGROUND

3. 3 Why NCI Supports Community- Based Cancer Research Majority of cancer care is provided in the community Access to large diverse patient populations Access to real world healthcare delivery settings Test feasibility of new interventions/processes Engage community oncologists in the research process to accelerate the uptake of evidence- based practice

4. 4 Why Include Cancer Care Delivery Research (CCDR) in NCORP? Precision medicine increasingly complicates care Rapidly changing health care system – Affordable Care Act – Accountable Care Organizations – Merging of practices – Diverse, often fragmented provision of care Urgent need for evidence about how these changes influence: – Patient outcomes – Disparities in care

5. 5 NCORP OVERVIEW

6. 6 What is NCORP? A community-based research program that 1.Builds upon the scope and activities of NCI’s previously supported community networks: – NCI Community Clinical Oncology Program (Community Clinical Oncology Programs, Minority-Based Clinical Oncology Programs, Research Bases) – NCI Community Cancer Centers Program 2. Integrates these prior networks into one new program to preserve and enhance cancer research in the community

7. 7 NCORP Research Expansion Cancer Prevention, Control and Screening/Post-Treatment Surveillance Clinical Trials and HRQOL Studies Treatment and Imaging Clinical Trials Minority/ Underserved Accrual Cancer Care Delivery Research

8. 8 What is the Overall Goal of NCORP? To bring cancer clinical trials, as well as cancer care delivery research (CCDR), to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.

9. 9 How Will NCORP Address this Goal? Design and conduct: – cancer prevention, control, and screening/post-treatment surveillance clinical trials – multi-level CCDR studies (e.g. patient, clinician, organization, system level) Enhance patient/provider access to treatment/imaging trials under the reorganized NCTN Facilitate minority/underserved participation in clinical research Increase integration of disparities research questions across all study types/settings Integrate primary/specialty care providers’, health services and behavioral researchers’ expertise with oncologists Accelerate knowledge transfer into clinical practice and healthcare systems and organizations

10. 10 How Will NCORP Be Structured? NCORP will consist of three components: Up to 7 Research Bases will serve as NCORP research hubs – to design and conduct multi-center cancer prevention, control and screening/post-treatment surveillance clinical trials and CCDR Up to 40 Community Sites will accrue participants – to trials conducted by NCORP Research Bases; NCTN treatment and imaging trials and quality of life studies; and CCDR studies involving patients, practitioners and/or healthcare organizations Up to 14 Minority/Underserved Community Sites will accrue participants – to trials conducted by NCORP Research Bases; NCI NCTN treatment and imaging trials and quality of life studies; and CCDR studies involving patients, practitioners and/or healthcare organizations – Will have a patient population comprising at least 30% racial/ethnic minorities or rural residents

11. 11 NCORP RESEARCH AGENDA

12. 12 What is the NCORP Clinical Trials Research Agenda? TypeFocus Cancer PreventionIdentify/evaluate interventions to reduce cancer risk and incidence Cancer ControlReduce incidence/co- morbidity of cancer and its treatment, enhance quality of life Cancer ScreeningEvaluate early diagnosis interventions and cancer recurrence NCTN Treatment TrialsIdentify secondary endpoints of health-related quality of life or patient- reported outcomes

13. 13 New Areas of Clinical Trials Research Will Include: Mechanisms of symptoms and treatment related toxicities Observational and longitudinal studies to understand natural history of symptoms and toxicities Post-treatment surveillance (e.g. tumor markers of recurrence, optimal screening modalities) Under and over-diagnosis Management of pre-cancerous lesions

14. 14 Cancer Care Delivery Research Definition Multidisciplinary field of scientific investigation Examines how social factors, financing systems, organizational structures/processes, health technologies, and healthcare provider and individual behaviors affect: – cancer outcomes – access to and quality of care – cancer care costs – health and well-being of cancer patients and survivors CCDR focus encompasses individuals, families, organizations, institutions, providers, communities, populations, and their interactions

15. 15 What is the NCORP CCDR Research Agenda? Scope of Research Interventional studiesCancer care delivery studies across care continuum. Examples include: Incorporation of patient reported information into clinical decision making Team-based care approaches Observational studiesInvestigations of organizations, providers and/or patients. Examples include: Patterns of care to study guideline/pathway adherence Alternative models/systems of care delivery NCORP Cancer Care Delivery Repository Generate hypotheses to promote multi-site research studies The breath and scope of data collected in the repository will be determined by the NCORP Cancer Care Delivery Research Coordinating Committee

16. 16 What is the NCORP Disparities Research Agenda? Address clinical trial and cancer care delivery research questions related to the more serious, prevalent cancers and cancer-related problems which disproportionately affect racial/ethnic minorities and other underserved populations Studies to enhance racial/ethnic minority and underserved participation in clinical trials Studies addressing determinants of disparities (e.g. social and health care system factors, co-morbidities, and genomics) Studies that evaluate differential outcomes in minority/underserved populations

17. 17 NCORP RESEARCH BASES (RFA-CA-012)

18. 18 NCORP Research Bases Will Serve as Research Hubs Must be located at leading institutions with comprehensive expertise in cancer clinical trials such as: Healthcare Research Organizations (including sites of Clinical Trials Cooperative Groups or NCTN Group Operations Centers) Community Clinical Oncology Research Bases NCI-designated Cancer Centers Integrated Healthcare Systems

19. 19 NCORP Research Bases Possess established organizational structure for designing and conducting multi-center clinical trials and CCDR studies including: – Administration, data management – Scientific and statistical leadership – Study operational processes and personnel – Regulatory compliance Are committed to: – Collaboration with other NCORP Research Bases and NCI – Participation in NCORP CCDR Coordinating Committee – Engaging extramural researcher participation

20. 20 NCORP COMMUNITY SITES (RFA-CA-013)

21. 21 NCORP Community Sites Consortium of community hospitals and/or Oncology practices or community-based integrated healthcare systems Accrue patients to clinical trials and CCDR studies

22. 22 NCORP Community Sites will Accrue a minimum of 80 new participant accruals evenly distributed over trials/studies in: TYPES OF TRIALS/STUDIES FOR ACCRUAL Have institutional/consortia participation commitment(s) Engage community partners Have capacity to support CCDR studies at a minimum of one component site TreatmentCancer Prevention and Control ImagingScreening, Post-treatment Surveillance

23. 23 NCORP MINORITY/UNDERSERVED COMMUNITY SITES (RFA-CA-014)

24. 24 NCORP Minority/Underserved Community Sites Consortia of community hospitals and/or Oncology practices Public hospitals Integrated health systems Academic medical centers May be an NCI-designated Cancer Center if certain requirements are met (see RFA) Patient population comprising at least 30% racial/ethnic minority or rural residents (see guidance at links below) http://www.whitehouse.gov/omb/fedreg_1997standards http://www.hrsa.gov/ruralhealth/policy/definition_of_rural.ht mlhttp://www.whitehouse.gov/omb/fedreg_1997standards http://www.hrsa.gov/ruralhealth/policy/definition_of_rural.ht ml; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449333/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449333/

25. 25 NCORP Minority/Underserved Community Sites Will: Accrue a minimum of 80 new participant accruals evenly distributed over trials/studies in: TYPES OF TRIALS/STUDIES FOR ACCRUAL – Under special circumstances accrual goals may be accomplished by the end of the project period Have institutional/consortia participation commitment(s) Engage community partners Support CCDR studies in at least one component site Mentor NCORP Community sites in disparities-focused research TreatmentCancer Prevention and Control ImagingScreening, Post-Treatment Surveillance

26. 26 NCORP MANAGEMENT AND STRUCTURE

27. 27 NCORP Core Collective Management Committee NCORP Director: Worta McCaskill- Stevens, MD, MS, Division of Cancer Prevention (DCP) NCORP Associate Director: Steve Clauser, PhD, Division of Cancer Control and Population Sciences (DCCPS)

28. 28 Division of Cancer Control and Population Sciences (DCCPS) NCORP Associate Director Center to Reduce Cancer Health Disparities (CRCHD) Division of Cancer Treatment and Diagnosis (DCTD) Division of Cancer Prevention (DCP) NCORP Director NCORP Organizational Structure NCI NCORP Research Bases: NCTN Groups Cancer Centers  Cancer Prevention and Control Trials  Cancer Care Delivery Community Sites: NCORP NCORP-Minority/ Underserved  Cancer Prevention and Control Trials  Treatment Trials  Cancer Care Delivery Extramural Investigators NCI-designated Cancer Centers Other Academic Centers Health Care Organizations Nonprofit Research Organizations Clinical Trials and Translational Research Advisory Committee (CTAC) Coordinating Center for Clinical Trials Evaluation and Prioritization of Research Concepts Steering Committee:  Disease specific  Symptom mgt./QOL  Cancer Care Delivery Central Institution Review Board CIRB Cancer Trials Support Unit CTSU National Clinical Trials Network (NCTN)  Treatment Trials

29. 29 NCORP TIMELINE AND INFORMATION SOURCES

30. 30 Timeframe for Applying to NCORP Nov. 8, 2013Jan. 8, 2014 September 2014September 2014 - 2019 Funding Opportunity Announcement Proposals from applicants due Scientific merit review 5-year NCORP awards made Period of performance March-April 2014 Dec. 8, 2013 Letters of Intent Due

31. 31 For RFA, Guidelines, FAQs and more detailed information on NCORP see: NIH Grants and Funding http://grants.nih.gov/grants/ NCI Division of Cancer Prevention http://prevention.cancer.gov/NCORP

32. 32