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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