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Clinical Trials Action Plan

Current Strategies to Implement Action Plan Objectives . Baseline Survey of Michigan Oncologists to Determine Clinical Trial Participation Consensus Document for Reimbursement of Routine Patient Care CostsIncreased Access to Trials in the CommunityProfessional Education Efforts to Showcase Michigan's Research InitiativesMinority Recruitment Coalitions.

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Clinical Trials Action Plan

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    1. Clinical Trials Action Plan By the year 2005 double the number and increase the diversity of participants enrolled in clinical cancer research

    3. Clinical Trials Baseline Survey

    4. Elements of the Survey Demographics of Michigan oncologists Current level of clinical trial participation Actual and perceived barriers to clinical trial participation Attitudes about clinical research

    5. Survey Development & Delivery Partnership with Pharmacia Corporation Educational design resources Financial sponsorship Compile and report data Recruited Authors of Survey Community and academic physicians Researchers and those who do not participate in clinical trials Michigan Society of Hem/Onc to administer Endorsement Distribution

    6. MSHO Clinical Trials Participation Survey Sample Questions (Strongly Agree to Strongly Disagree)

    7. Anticipated Survey Benefits Measure current participation levels Use survey results to identify research concerns and barriers oncologists report Identify possible behavioral change opportunities for physicians who do not enroll patients on studies Use subsequent survey to measure progress

    8. Consensus Guidelines for Coverage of Routine Patient Care Costs for Those Enrolled in Clinical Trials

    9. Essential Steps Preceding Consensus Guideline Draft Awareness and education programs Coalition of major stakeholders in the care of Michigan cancer patients - Providers - Legislators - Payers - Patient Advocates recruited to form The Michigan Working Group to Improve Cancer Outcomes.

    10. Michigan Working Group to Improve Cancer Outcomes Ford Motors General Motors Kellogg UAW Economic Alliance for Michigan Henry Ford Health System Karmanos Cancer Institute MSU Cancer Center U of M Cancer Center St. John’s Health System St. Joseph Mercy Hospital MI Department of Community Health NCI Cancer Information Service MI Society of Hem/Onc Coalition of National Cancer Cooperative Groups Blue Cross Blue Shield of Michigan Health Alliance Plan MI Association of Health Plans Aetna US Healthcare Michigan Farm Bureau American Community Mutual American Cancer Society Prostate Education Support Network Leukemia & Lymphoma Society Amgen Pharmacia Corporation Senator Schwartz Senator Shugars MI Hospital Association

    11. Timeline March 5, 1999 - MSHO, MSMS and ACS stages Clinical Trials: Building Partnerships for the Future forum November 3, 1999 - Senator Schwarz convenes meeting at the Capitol; members charged to develop non-mandated solution to coverage of patient care costs February 23, 2000 - The Michigan Working Group to Improve Cancer Outcomes is formed and empowers an Executive Group to draft consensus guidelines April 6 – December 7, 2000 – Executive Group collaborates to draft a viable document February, 2001 – Michigan Working Group will review Consensus Document and present to their constituencies for endorsement

    12. Michigan Working Group to Improve Cancer Outcomes Executive Group Membership

    13. Outline of the Consensus Document Clinical Trial Definitions and Exclusions Rationale for Supporting Clinical Research Efforts Criteria for “Approved” Clinical Trials Costs Associated with Cancer Clinical Trials Policy Issues and Concerns Essential Elements of Consensus Guidelines

    14. Increase Access to Clinical Trials in the Community

    15. Growth of CCOPs in Michigan Ann Arbor Regional CCOP Kalamazoo CCOP Grand Rapids CCOP

    16. Growth of Clinical Trial Networks Academic centers partner with community hospitals Local programs strengthened by expanded resources Access to quality trials increases for physicians and their patients

    17. Clinical Trial Professional Education Efforts

    18. Continuing Medical Education ASH Updates ASCO Updates MSHO Showcase of MI Research Initiatives

    19. Nursing Education “Today’s Treatments Were Yesterday’s Clinical Trials” – MSHO Nurse Network Retreat Clinical Trials Workshop (Partnership with MSHO/Bristol)

    20. Minority Recruitment Efforts

    21. Exploratory Meeting/ African American Thought Leaders MDCH identifies and invites prominent African American leaders to meet with the directors of Michigan’s research programs. Feasibility of a “Blue Ribbon” advisory panel will be proposed for collaboration on strategies to resolve insufficient minority participation in clinical research.

    22. The Secret of our Success?

    23. BRING THE RIGHT PEOPLE TO THE TABLE

    24. HAVE ENOUGH $$$$ TO COMPLETE THE PROJECT

    25. CONSISTENT ADMINISTRATIVE SUPPORT Scheduling Membership maintenance Reports, agendas, minutes Follow-up Follow-up Follow-up

    26. What Does the Future Hold?

    27. Partnering Capitalize on networking contacts cultivated in the Michigan Working Group to Improve Cancer Outcomes Identify and develop partnering opportunities with pharmaceutical companies using their marketing, education and funding resources.

    28. Building on Achievements Use survey results to assess physician bias and misperceptions. Expand the potential of the Michigan Working Group to Improve Cancer Outcomes from approval of research to support. Use CMEs to update awareness of MI research initiatives

    29. Engage MCC Resources Develop and maintain central web-based registry of Michigan clinical trials Form Michigan Commission on Clinical Research to review trials which are not “slam dunks” within the context of the Consensus Guidelines Designate a neutral body to monitor and measure research initiatives

    30. Staying on Target Revisit Action Plan Strategies Work Plan Timeline Implementation Progress Monitoring

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