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The Cancer Consortium

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  1. The Cancer Consortium Deborah Schrag, MD (PI) Caprice Christian Greenberg, MD, MPH Brigham and Women’s Hospital Dana-Farber Cancer Institute

  2. 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

  3. 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

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

  5. Cancer Consortium • Coordinating Center • Brigham and Women’s 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

  6. 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

  7. 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

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

  9. 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

  10. 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

  11. 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

  12. 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)

  13. 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 • Team’s own level of interest, expertise and enthusiasm for conducting these analyses

  14. 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

  15. 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

  16. Stakeholder Support and Meeting

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

  18. 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 Stakeholder Committee

  19. 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

  20. 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

  21. 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

  22. 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