The Cancer Consortium

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The Cancer Consortium

• Deborah Schrag, MD (PI)
• Caprice Christian Greenberg, MD, MPH
• Brigham and Womens Hospital
• Dana-Farber Cancer Institute

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Why Cancer?

• Burden
• 1.4 million new cancer cases in 2008
• 566,000 cancer deaths
• Costly
• Cancer treatment 5 national health expenditures
• Variation in treatment
• Small efficacy trials can lead to FDA approval of
  new agents with uncertain effectiveness in the
  broader population
• Not all interventions are evaluated with RCTs

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The Goals

• How do we move from the evidence base provided by
  efficacy trials to non-trial cancer population?
• Provide expertise in and advance the development
  of CER in cancer
• Ensure stakeholder input
• Assist AHRQ and policymakers in prioritizing
  cancer-related research

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Consortium Structure
Data Committee
Methods Committee
Executive Committee AHRQ BWH/DFCI UNC
Stakeholder Committee
Clinical Committee
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Cancer Consortium

• Coordinating Center
• Brigham and Womens Hospital and the Dana-Farber
  Cancer Institute
• Deborah Schrag, CAN DEcIDE PI
• Sebastian Schneeweiss, DEcIDE PI
• Caprice Greenberg MD, Lead Stakeholder Input
• Affiliate Center
• University of North Carolina
• Michael Murray, DEcIDE PI
• William Carpenter, PhD, CAN DEcIDE PI

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Current Work Assignments

• 1. Chemotherapy for stage III/IV colorectal
  cancer in diverse populations
• 2. Analytic Briefs for Supporting Comparative
  Effectiveness Research and Systematic Reviews in
  Cancer
• 3. Stakeholder Support and Meeting
• 4. Biologic therapy in colorectal cancer
• 5. Anticoagulation for Venous Thromboembolic
  Events in Patients with Cancer

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Current Work Assignments

• 1. Chemotherapy for stage III/IV colorectal
  cancer in diverse populations
• 2. Analytic Briefs for Supporting CER and
  Systematic Reviews in Cancer
• 3. Stakeholder Support and Meeting
• 4. Biologic therapy in colorectal cancer
• 5. Anticoagulation for Venous Thromboembolic
  Events in Patients with Cancer

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Analytic Briefs for Supporting Comparative
Effectiveness Research and Systematic Reviews in
Cancer
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Phase 1 Identifying Options for Implementation

• Identification of prospective drugs, devices and
  diagnostics for study
• Identification of prospective datasets for
  examination of these interventions
• Development and refinement of reporting format
  that is most conducive to stakeholder uptake of
  analysis results

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Phase 1 Identifying Options for Implementation

• Identification of prospective drugs, devices and
  diagnostics for study
• High-risk drugs
• Drugs that build to high-volume utilization
• Those that are more expensive than alternatives
• Identification of prospective datasets for
  examination of these interventions
• Development and refinement of reporting format
  that is most conducive to stakeholder uptake of
  analysis results

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Phase 1 Identifying Options for Implementation

• Identification of prospective drugs, devices and
  diagnostics for study
• Identification of prospective datasets for
  examination of these interventions
• SEER-Medicare
• CanCORS
• Carolina Mammography Registry
• Development and refinement of reporting format
  that is most conducive to stakeholder uptake of
  analysis results

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Phase 1 Identifying Options for Implementation

• Identification of prospective drugs, devices and
  diagnostics for study
• Identification of prospective datasets for
  examination of these interventions
• Development and refinement of reporting format
  that is most conducive to stakeholder uptake of
  analysis results
• Real-time reports (ongoing monitoring)
• Final reports (drug effectiveness review)

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Phase 2 Topic Generation for CE Analysis

• Criteria for selection
• Impact in terms of number of lives with special
  consideration of the impact for federal programs
  Medicare and Medicaid
• Feasibility in terms of data sources available
  within rapid time frame of DEcIDE contract
• Teams own level of interest, expertise and
  enthusiasm for conducting these analyses

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Phase 2 Topic Generation for CE Analysis

• Examples of potential topics
• LMWH v. Coumadin to prevent recurrent VTE for
  advanced cancer patients
• Chemoprevention of Breast Cancer
• No treatment, Tamoxifen, Raloxifene, Letrozole
• G-CSF v. no G-CSF for prophylaxis against febrile
  neutropenia that are moderately myelosupressive

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Phase 2 Topic Generation for CE Analysis

• Additional topics generated
• Prevention
• Smoking cessation treatments
• Diagnoses
• Different technologies for breast cancer
  screening (mammogram v. MRI)
• Treatment
• Brachytherapy v. standard v. proton beam
  radiation for prostate cancer
• Supportive Care
• Zyprexa for palliation of symptoms at the close
  of life

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Stakeholder Support and Meeting
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Main Objective

• Identify and convene a stakeholder committee
• Develop research protocol concepts for the
  highest impact areas to be addressed in cancer CER

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Stakeholder Committee

• Fall, 2009 - Kick-off meeting
• Assemble the constituency
• Determine proposed role in future CE studies
• Generate and prioritize proposed research topics
• Spring, 2010 Follow-up meeting
• Review and refine proposed topics
• Identify top priority areas for CER by consortium
• Infrastructure will allow ongoing collaboration
  and continuous interfacing with stakeholders

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Stakeholder Examples - 1

• Federal Agencies
• National Cancer Institute
• Center for Disease Control
• Center for Medicare and Medicaid
• Payors
• Blue Cross/Blue Shield
• Hospital Corporation of America
• Cancer Research Network
• UnitedHealth Group

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Stakeholder Examples - 2

• Professional Societies
• American Cancer Society
• American Society of Clinical Oncology
• American College of Surgeons
• Society of Surgical Oncology
• American Society of Therapeutic Radiation and
  Oncology
• Oncology Nursing Society
• American Society for Clinical Pathology

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Plan for Development

• Stage 1 Prioritized list of topics
• generated at the Stakeholder Meeting 1
• Stage 2 Project proposals
• Each priority topic will be developed into a 1
  page summary by the study team
• Presented for feedback at Stakeholder Meeting 2
• Stage 3 Research protocol concepts

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Deliverables

• CER Protocol Concepts
• Designed to develop scientific evidence that will
  meet the needs of defined stakeholders for
  decision making, whether at the patient,
  clinician or policy level
• Submitted to AHRQ for peer review and potentially
  public review
• Research to be carried out by the Consortium,
  other DEcIDE Centers or through other AHRQ
  programs