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The Cancer ConsortiumThe Cancer Consortium

Deborah Schrag, MD (PI)Deborah Schrag, MD (PI)

Caprice Christian Greenberg, MD, MPHCaprice Christian Greenberg, MD, MPH

Brigham and Women’s HospitalBrigham and Women’s Hospital

Dana-Farber Cancer InstituteDana-Farber Cancer Institute

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Why Cancer?Why Cancer?

BurdenBurden– 1.4 million new cancer cases in 20081.4 million new cancer cases in 2008

– 566,000 cancer deaths566,000 cancer deaths

CostlyCostly– Cancer treatment ~5% national health expendituresCancer treatment ~5% national health expenditures

Variation in treatmentVariation in treatment Small efficacy trials can lead to FDA approval of Small efficacy trials can lead to FDA approval of

new agents with uncertain effectiveness in the new agents with uncertain effectiveness in the broader populationbroader population

Not all interventions are evaluated with RCTsNot all interventions are evaluated with RCTs

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The GoalsThe Goals

How do we move from the evidence How do we move from the evidence base provided by efficacy trials to “non-base provided by efficacy trials to “non-trial” cancer population?trial” cancer population?

Provide expertise in and advance the Provide expertise in and advance the development of CER in cancerdevelopment of CER in cancer

Ensure stakeholder inputEnsure stakeholder input Assist AHRQ and policymakers in Assist AHRQ and policymakers in

prioritizing cancer-related researchprioritizing cancer-related research

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DataCommittee

ClinicalCommittee

MethodsCommittee

StakeholderCommittee

Executive Committee

AHRQ

BWH/DFCI

UNC

Consortium StructureConsortium Structure

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Cancer ConsortiumCancer Consortium

Coordinating CenterCoordinating Center– Brigham and Women’s Hospital and the Dana-Farber Cancer InstituteBrigham and Women’s Hospital and the Dana-Farber Cancer Institute– Deborah Schrag, CAN DEcIDE PIDeborah Schrag, CAN DEcIDE PI– Sebastian Schneeweiss, DEcIDE PISebastian Schneeweiss, DEcIDE PI– Caprice Greenberg MD, Lead Stakeholder InputCaprice Greenberg MD, Lead Stakeholder Input

Affiliate CenterAffiliate Center– University of North CarolinaUniversity of North Carolina– Michael Murray, DEcIDE PIMichael Murray, DEcIDE PI– William Carpenter, PhD, CAN DEcIDE PI William Carpenter, PhD, CAN DEcIDE PI

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Current Work AssignmentsCurrent Work Assignments

1. Chemotherapy for stage III/IV colorectal 1. Chemotherapy for stage III/IV colorectal cancer in diverse populationscancer in diverse populations

2. Analytic Briefs for Supporting 2. Analytic Briefs for Supporting Comparative Effectiveness Research and Comparative Effectiveness Research and Systematic Reviews in CancerSystematic Reviews in Cancer

3. Stakeholder Support and Meeting3. Stakeholder Support and Meeting4. Biologic therapy in colorectal cancer4. Biologic therapy in colorectal cancer5. Anticoagulation for Venous 5. Anticoagulation for Venous

Thromboembolic Events in Patients with Thromboembolic Events in Patients with Cancer Cancer

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Current Work AssignmentsCurrent Work Assignments

1. Chemotherapy for stage III/IV colorectal 1. Chemotherapy for stage III/IV colorectal cancer in diverse populationscancer in diverse populations

2. Analytic Briefs for Supporting CER and 2. Analytic Briefs for Supporting CER and Systematic Reviews in CancerSystematic Reviews in Cancer

3. Stakeholder Support and Meeting3. Stakeholder Support and Meeting

4. Biologic therapy in colorectal cancer4. Biologic therapy in colorectal cancer

5. Anticoagulation for Venous 5. Anticoagulation for Venous Thromboembolic Events in Patients with Thromboembolic Events in Patients with Cancer Cancer

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Analytic Briefs for Supporting Analytic Briefs for Supporting Comparative Effectiveness Comparative Effectiveness

Research and Systematic Reviews Research and Systematic Reviews in Cancerin Cancer

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Phase 1: Identifying Options Phase 1: Identifying Options for Implementationfor Implementation

Identification of prospective drugs, Identification of prospective drugs, devices and diagnostics for studydevices and diagnostics for study

Identification of prospective datasets for Identification of prospective datasets for examination of these interventionsexamination of these interventions

Development and refinement of Development and refinement of reporting format that is most conducive reporting format that is most conducive to stakeholder uptake of analysis resultsto stakeholder uptake of analysis results

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Phase 1: Identifying Options Phase 1: Identifying Options for Implementationfor Implementation

Identification of prospective drugs, devices Identification of prospective drugs, devices and diagnostics for studyand diagnostics for study– High-risk drugsHigh-risk drugs

– Drugs that build to high-volume utilizationDrugs that build to high-volume utilization

– Those that are more expensive than alternativesThose that are more expensive than alternatives

Identification of prospective datasets for Identification of prospective datasets for examination of these interventionsexamination of these interventions

Development and refinement of reporting Development and refinement of reporting format that is most conducive to stakeholder format that is most conducive to stakeholder uptake of analysis resultsuptake of analysis results

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Phase 1: Identifying Options Phase 1: Identifying Options for Implementationfor Implementation

Identification of prospective drugs, devices Identification of prospective drugs, devices and diagnostics for studyand diagnostics for study

Identification of prospective datasets for Identification of prospective datasets for examination of these interventionsexamination of these interventions– SEER-MedicareSEER-Medicare

– CanCORSCanCORS

– Carolina Mammography RegistryCarolina Mammography Registry

Development and refinement of reporting Development and refinement of reporting format that is most conducive to stakeholder format that is most conducive to stakeholder uptake of analysis resultsuptake of analysis results

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Phase 1: Identifying Options Phase 1: Identifying Options for Implementationfor Implementation

Identification of prospective drugs, Identification of prospective drugs, devices and diagnostics for studydevices and diagnostics for study

Identification of prospective datasets for Identification of prospective datasets for examination of these interventionsexamination of these interventions

Development and refinement of Development and refinement of reporting format that is most conducive reporting format that is most conducive to stakeholder uptake of analysis resultsto stakeholder uptake of analysis results– Real-time reports (ongoing monitoring)Real-time reports (ongoing monitoring)

– Final reports (drug effectiveness review)Final reports (drug effectiveness review)

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Phase 2: Topic Generation for Phase 2: Topic Generation for CE AnalysisCE Analysis

Criteria for selectionCriteria for selection– Impact in terms of number of lives with Impact in terms of number of lives with

special consideration of the impact for special consideration of the impact for federal programs Medicare and Medicaidfederal programs Medicare and Medicaid

– Feasibility in terms of data sources available Feasibility in terms of data sources available within rapid time frame of DEcIDE contractwithin rapid time frame of DEcIDE contract

– Team’s own level of interest, expertise and Team’s own level of interest, expertise and enthusiasm for conducting these analysesenthusiasm for conducting these analyses

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Phase 2: Topic Generation for Phase 2: Topic Generation for CE AnalysisCE Analysis

Examples of potential topicsExamples of potential topics– LMWH v. Coumadin to prevent recurrent LMWH v. Coumadin to prevent recurrent

VTE for advanced cancer patientsVTE for advanced cancer patients

– Chemoprevention of Breast CancerChemoprevention of Breast Cancer No treatment, Tamoxifen, Raloxifene, LetrozoleNo treatment, Tamoxifen, Raloxifene, Letrozole

– G-CSF v. no G-CSF for prophylaxis against G-CSF v. no G-CSF for prophylaxis against febrile neutropenia that are moderately febrile neutropenia that are moderately myelosupressivemyelosupressive

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Phase 2: Topic Generation for Phase 2: Topic Generation for CE AnalysisCE Analysis

Additional topics generatedAdditional topics generated– PreventionPrevention

Smoking cessation treatmentsSmoking cessation treatments

– DiagnosesDiagnoses Different technologies for breast cancer Different technologies for breast cancer

screening (mammogram v. MRI)screening (mammogram v. MRI)

– TreatmentTreatment Brachytherapy v. standard v. proton beam Brachytherapy v. standard v. proton beam

radiation for prostate cancerradiation for prostate cancer

– Supportive CareSupportive Care Zyprexa for palliation of symptoms at the close Zyprexa for palliation of symptoms at the close

of lifeof life

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Stakeholder Support and MeetingStakeholder Support and Meeting

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Main ObjectiveMain Objective

Identify and convene a stakeholder Identify and convene a stakeholder committeecommittee

Develop research protocol concepts for Develop research protocol concepts for the highest impact areas to be the highest impact areas to be addressed in cancer CERaddressed in cancer CER

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Stakeholder CommitteeStakeholder Committee

Fall, 2009 - Kick-off meetingFall, 2009 - Kick-off meeting– Assemble the constituencyAssemble the constituency

– Determine proposed role in future CE studiesDetermine proposed role in future CE studies

– Generate and prioritize proposed research topicsGenerate and prioritize proposed research topics

Spring, 2010 – Follow-up meetingSpring, 2010 – Follow-up meeting– Review and refine proposed topicsReview and refine proposed topics

– Identify top priority areas for CER by consortiumIdentify top priority areas for CER by consortium

Infrastructure will allow ongoing collaboration Infrastructure will allow ongoing collaboration and continuous interfacing with stakeholdersand continuous interfacing with stakeholders

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Stakeholder Examples - 1Stakeholder Examples - 1

Federal AgenciesFederal Agencies– National Cancer InstituteNational Cancer Institute

– Center for Disease ControlCenter for Disease Control

– Center for Medicare and MedicaidCenter for Medicare and Medicaid

PayorsPayors– Blue Cross/Blue ShieldBlue Cross/Blue Shield

– Hospital Corporation of AmericaHospital Corporation of America

– Cancer Research NetworkCancer Research Network

– UnitedHealth GroupUnitedHealth Group

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Stakeholder Examples - 2Stakeholder Examples - 2

Professional SocietiesProfessional Societies– American Cancer SocietyAmerican Cancer Society

– American Society of Clinical OncologyAmerican Society of Clinical Oncology

– American College of SurgeonsAmerican College of Surgeons

– Society of Surgical OncologySociety of Surgical Oncology

– American Society of Therapeutic Radiation American Society of Therapeutic Radiation and Oncologyand Oncology

– Oncology Nursing SocietyOncology Nursing Society

– American Society for Clinical PathologyAmerican Society for Clinical Pathology

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Plan for DevelopmentPlan for Development

Stage 1: Prioritized list of topicsStage 1: Prioritized list of topics– generated at the Stakeholder Meeting #1generated at the Stakeholder Meeting #1

Stage 2: Project proposalsStage 2: Project proposals– Each priority topic will be developed into a 1 Each priority topic will be developed into a 1

page summary by the study teampage summary by the study team

– Presented for feedback at Stakeholder Presented for feedback at Stakeholder Meeting #2Meeting #2

Stage 3: Research protocol conceptsStage 3: Research protocol concepts

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DeliverablesDeliverables

CER Protocol ConceptsCER Protocol Concepts– Designed to develop scientific evidence Designed to develop scientific evidence

that will meet the needs of defined that will meet the needs of defined stakeholders for decision making, whether stakeholders for decision making, whether at the patient, clinician or policy levelat the patient, clinician or policy level

– Submitted to AHRQ for peer review and Submitted to AHRQ for peer review and potentially public reviewpotentially public review

– Research to be carried out by the Research to be carried out by the Consortium, other DEcIDE Centers or Consortium, other DEcIDE Centers or through other AHRQ programsthrough other AHRQ programs