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Division of General Internal Medicine

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Division of General Internal Medicine

Short Courses: Cost-Effectiveness Analysis Alongside Clinical Trials

ISPOR 9th Annual European Congress
9:00 - 12:00, October 29, 2006

Course Description:

Growing numbers of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory/reimbursement requirements of many countries that consider evidence of economic value along with clinical efficacy. This course presents the design, conduct, and reporting of cost-effectiveness analyses alongside clinical trials based on, in part, the Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report. Trial design, selecting data elements, database design and management, analysis, and results reporting are presented. Trials evaluating effectiveness and clinical outcome measures are discussed. Obtaining health resource use and health state utilities directly from study subjects and economic data collection fully integrated into the study are discussed. Analyses guided by an analysis plan and hypotheses, an incremental analysis using an intention to treat approach, characterization of uncertainty, and standards for reporting results are presented. This course is introductory/intermediate. Familiarity with economic evaluations will be helpful.

Lecture Notes

  • Scott Ramsey, University of Washington

  • Henry Glick, PhD, University of Pennsylvania