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

2. 2 Why Cancer? Burden Burden – 1.4 million new cancer cases in 2008 – 566,000 cancer deaths Costly Costly – Cancer treatment ~5% national health expenditures Variation in treatment Variation in treatment Small efficacy trials can lead to FDA approval of new agents with uncertain effectiveness in the broader population 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 Not all interventions are evaluated with RCTs

3. 3 The Goals How do we move from the evidence base provided by efficacy trials to “non- trial” cancer population? 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 Provide expertise in and advance the development of CER in cancer Ensure stakeholder input Ensure stakeholder input Assist AHRQ and policymakers in prioritizing cancer-related research Assist AHRQ and policymakers in prioritizing cancer-related research

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

5. 5 Cancer Consortium Coordinating Center 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 Affiliate Center – University of North Carolina – Michael Murray, DEcIDE PI – William Carpenter, PhD, CAN DEcIDE PI

6. 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. 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. 8 Analytic Briefs for Supporting Comparative Effectiveness Research and Systematic Reviews in Cancer

9. 9 Phase 1: Identifying Options for Implementation Identification of prospective drugs, devices and diagnostics for study Identification of prospective drugs, devices and diagnostics for study Identification of prospective datasets for examination of these interventions 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 Development and refinement of reporting format that is most conducive to stakeholder uptake of analysis results

10. 10 Phase 1: Identifying Options for Implementation Identification of prospective drugs, devices and diagnostics for study 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 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 Development and refinement of reporting format that is most conducive to stakeholder uptake of analysis results

11. 11 Phase 1: Identifying Options for Implementation Identification of prospective drugs, devices and diagnostics for study Identification of prospective drugs, devices and diagnostics for study Identification of prospective datasets for examination of these interventions 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 Development and refinement of reporting format that is most conducive to stakeholder uptake of analysis results

12. 12 Phase 1: Identifying Options for Implementation Identification of prospective drugs, devices and diagnostics for study Identification of prospective drugs, devices and diagnostics for study Identification of prospective datasets for examination of these interventions 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 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. 13 Phase 2: Topic Generation for CE Analysis Criteria for selection 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. 14 Phase 2: Topic Generation for CE Analysis Examples of potential topics Examples of potential topics – LMWH v. Coumadin to prevent recurrent VTE for advanced cancer patients – Chemoprevention of Breast Cancer No treatment, Tamoxifen, Raloxifene, Letrozole No treatment, Tamoxifen, Raloxifene, Letrozole – G-CSF v. no G-CSF for prophylaxis against febrile neutropenia that are moderately myelosupressive

15. 15 Phase 2: Topic Generation for CE Analysis Additional topics generated Additional topics generated – Prevention Smoking cessation treatments Smoking cessation treatments – Diagnoses Different technologies for breast cancer screening (mammogram v. MRI) Different technologies for breast cancer screening (mammogram v. MRI) – Treatment Brachytherapy v. standard v. proton beam radiation for prostate cancer Brachytherapy v. standard v. proton beam radiation for prostate cancer – Supportive Care Zyprexa for palliation of symptoms at the close of life Zyprexa for palliation of symptoms at the close of life

16. 16 Stakeholder Support and Meeting

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

18. 18 Stakeholder Committee Fall, 2009 - Kick-off meeting 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 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 Infrastructure will allow ongoing collaboration and continuous interfacing with stakeholders

19. 19 Stakeholder Examples - 1 Federal Agencies Federal Agencies – National Cancer Institute – Center for Disease Control – Center for Medicare and Medicaid Payors Payors – Blue Cross/Blue Shield – Hospital Corporation of America – Cancer Research Network – UnitedHealth Group

20. 20 Stakeholder Examples - 2 Professional Societies 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. 21 Plan for Development Stage 1: Prioritized list of topics Stage 1: Prioritized list of topics – generated at the Stakeholder Meeting #1 Stage 2: Project proposals 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 Stage 3: Research protocol concepts

22. 22 Deliverables CER Protocol Concepts 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