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VA Comparative Effectiveness Research

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VA Comparative Effectiveness Research

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    1. VA Comparative Effectiveness Research Robert M Califf Vice Chancellor for Clinical Resesarch—Duke University

    2. The VA as a “closed loop” system The VA as a collaborator in a national system The VA as a collaborator in a global system

    3. The Cycle of Quality: Generating Evidence to Inform Policy

    4. Building a National CTSA Consortium When fully implemented by 2011, the initiative is expected to provide a total of about $500 million annually to 60 research institutions. When fully implemented by 2011, the initiative is expected to provide a total of about $500 million annually to 60 research institutions.

    5. Sharing a Common Vision

    6. Goals for the CTSA Consortium The CTSA consortium has the following five goals: Building National Clinical and Translational Research Capability Training and Career Development of Clinical and Translational Scientists Enhancing Consortium-Wide Collaborations Enhancing the Health of our Communities and the Nation Encouraging T1 Translational Research

    7. Clinical and Genomic Profiling to Prediction Outcome and Treatment Response

    9. Personal Health Record

    10. The Clinical Trials System Too slow Too expensive Doesn’t answer many critical questions Otherwise its great

    12. Clinical Trial Cost Estimates

    13. Data gathered by the Tufts Center for the Study of Drug Development (Tufts CSDD) >90% of all clinical trials delayed due to over-ambitious timelines and difficulty with patient enrollment Top reasons for delays in trials: Protracted budget negotiations Slow IRB review and approval Poor patient recruitment and retention Estimated 20% of PIs fail to enroll a single patient and 30% under-enroll in a given trial Between 2000 and 2005 38% of PIs who participated in clinical trials in a given year did not return in a subsequent year through 2008 Up from 26% in previous 5 years

    14. Patient Recruitment and Retention

    16. Putting It All Together Clinical research is a benefit for Americans. - With comparative effectiveness it is an explicit policy goal. We need to stop pushing this work offshore. We need to modernize the infrastructure for clinical research (electronic systems under ARRA). We need to modernize the administrative infrastructure for this work: Human subjects protection Contracting Compliance

    17. A collaborative effort to find solutions In light of these issues the U.S. FDA’s Office of Critical Path Programs and Duke University joined together as founding members of a public-private partnership: The Clinical Trials Transformation Initiative (CTTI) All stakeholders are involved in this initiative including government, industry, academia, patient advocates, professional societies, and others www.trialstransformation.org

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