Clinical Trials Action Plan

Clinical Trials Action Plan By the year 2005 double the number and increase the diversity of participants enrolled in clinical cancer research 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 Costs • Increased Access to Trials in the Community • Professional Education Efforts to Showcase Michigan’s Research Initiatives • Minority Recruitment Coalitions Clinical Trials Baseline Survey 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 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 MSHO Clinical Trials Participation Survey Sample Questions (Strongly Agree to Strongly Disagree) 1. My practice is limited by the hospital or HMO formulary. 2. Hospital policy dictates some of my treatment options. 3. Protocols do not include all patients and are therefore too restrictive. 4. My income is adversely affected by placing patients on clinical trials. 5. Protocols do not always include what I consider standard therapy. 6. I am concerned about being audited by insurers who exclude payments for clinical trials. 7. Other responsibilities prevent me from learning what I need to know to place patients on clinical trials. 8. Protocols require a large increase in time spent on each patient. 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 Consensus Guidelines for Coverage of Routine Patient Care Costs for Those Enrolled in Clinical Trials 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. 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 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 Michigan Working Group to Improve Cancer Outcomes Executive Group Membership Michigan Society of Hematology and Oncology General Motors University of Michigan Cancer Center Blue Cross Blue Shield of Michigan Michigan Department of Community Health American Cancer Society, Great Lakes Division Prostate Education and Support Network of Michigan Aetna US Healthcare Ford Motor Karmanos Cancer Institute Health Alliance Plan Michigan Hospital Association International Union,UAW Josephine Ford Cancer Center Henry Ford H.S. Michigan State University Cancer Center Michigan Association of Health Plans Wisconsin Physician Services Medicare Part B Pharmacia Corporation Economic Alliance for Michigan Amgen Incorporated 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 Increase Access to Clinical Trials in the Community Growth of CCOPs in Michigan • Ann Arbor Regional CCOP • Kalamazoo CCOP • Grand Rapids CCOP 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 Clinical Trial Professional Education Efforts Continuing Medical Education • ASH Updates • ASCO Updates • MSHO Showcase of MI Research Initiatives Nursing Education • “Today’s Treatments Were Yesterday’s Clinical Trials” – MSHO Nurse Network Retreat • Clinical Trials Workshop (Partnership with MSHO/Bristol) Minority Recruitment Efforts 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. The Secret of our Success? BRING THE RIGHT PEOPLE TO THE TABLE Identify the essential institutions/agencies Invite the Decision Makers in that group HAVE ENOUGH $$$$ TO COMPLETE THE PROJECT CONSISTENT ADMINISTRATIVE SUPPORT • Scheduling • Membership maintenance • Reports, agendas, minutes • Follow-up • Follow-up • Follow-up What Does the Future Hold? 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. 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 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 Staying on Target • Revisit Action Plan Strategies • Work Plan • Timeline • Implementation • Progress Monitoring