1 NCORP Overview November 2013 NCORP Director Worta McCaskill-Stevens, MD, MS Chief, Community...
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Transcript of 1 NCORP Overview November 2013 NCORP Director Worta McCaskill-Stevens, MD, MS Chief, Community...
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NCORPOverview November 2013
NCORP DirectorWorta McCaskill-Stevens, MD, MSChief, Community Oncology and Prevention Trials Research GroupDivision of Cancer Prevention
NCORP Associate DirectorSteven Clauser, PhDChief, Outcomes Research BranchDivision of Cancer Control & Population Sciences
In Collaboration with the NCI Division of Cancer Treatment and Diagnosisand the NCI Center to Reduce Cancer Health Disparities
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BACKGROUND
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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
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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
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NCORP OVERVIEW
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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
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NCORP Research Expansion
Cancer Prevention, Control and Screening/Post-Treatment SurveillanceClinical Trials and HRQOL Studies
Treatment and Imaging Clinical Trials
Minority/Underserved Accrual
Cancer Care
DeliveryResearch
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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.
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How Will NCORP Address thisGoal? • 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
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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
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NCORP RESEARCH AGENDA
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What is the NCORP Clinical Trials Research Agenda?
Type FocusCancer Prevention Identify/evaluate
interventions to reduce cancer risk and incidence
Cancer Control Reduce incidence/co-morbidity of cancer and its treatment, enhance quality of life
Cancer Screening Evaluate early diagnosis interventions and cancer recurrence
NCTN Treatment Trials Identify secondary endpoints of health-related quality of life or patient-reported outcomes
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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
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Cancer Care Delivery ResearchDefinition
• 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
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What is the NCORP CCDR Research Agenda?
Scope of Research
Interventional studies Cancer care delivery studies across care continuum. Examples include:• Incorporation of patient reported information
into clinical decision making• Team-based care approaches
Observational studies Investigations 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
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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
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NCORP RESEARCH BASES (RFA-CA-012)
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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
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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
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NCORP COMMUNITY SITES (RFA-CA-013)
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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
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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
Treatment Cancer Prevention and Control
Imaging Screening, Post-treatment Surveillance
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NCORP MINORITY/UNDERSERVED COMMUNITY SITES (RFA-CA-014)
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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.html; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449333/
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NCORP Minority/Underserved Community SitesWill:
• 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
Treatment Cancer Prevention and Control
Imaging Screening, Post-Treatment Surveillance
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NCORP MANAGEMENT AND STRUCTURE
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NCORP Core Collective ManagementCommittee
• 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)
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Division of CancerControl and PopulationSciences (DCCPS)
NCORP Associate Director
Center to Reduce Cancer Health Disparities (CRCHD)
Division of CancerTreatment and Diagnosis (DCTD)
Division of Cancer Prevention(DCP)
NCORP Director
NCORP Organizational StructureNCI
NCORPResearch Bases:NCTN GroupsCancer Centers
Cancer Prevention and Control Trials
Cancer Care Delivery
Community Sites:NCORPNCORP-Minority/
UnderservedCancer Prevention
and Control TrialsTreatment TrialsCancer Care
DeliveryExtramural InvestigatorsNCI-designated Cancer CentersOther Academic CentersHealth Care OrganizationsNonprofit Research
Organizations
Clinical Trials and Translational Research Advisory Committee (CTAC)
Coordinating Centerfor Clinical Trials
Evaluation and Prioritization of Research Concepts
Steering Committee:Disease specificSymptom mgt./QOLCancer Care Delivery
CentralInstitutionReviewBoard
CIRBCancerTrialsSupportUnit
CTSU
National ClinicalTrials Network(NCTN)
Treatment Trials
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NCORP TIMELINE AND INFORMATION SOURCES
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Timeframe for Applying to NCORP
Nov. 8, 2013 Jan. 8, 2014
September 2014September 2014 - 2019
Funding Opportunity Announcement
Proposals from applicants due
Scientific merit review
5-year NCORPawards made
Period ofperformance
March-April 2014
Dec. 8, 2013
Letters of Intent Due
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For RFA, Guidelines, FAQs and more detailed information on NCORP see:
NIH Grants and Fundinghttp://grants.nih.gov/grants/
NCI Division of Cancer Preventionhttp://prevention.cancer.gov/NCORP
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