It is becoming increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. The results of such analysis can affect reimbursement decisions for new medical technologies, for example drugs, devices or diagnostics; aid companies seeking to make claims about the cost-effectiveness of their product; allow early consideration of the economic value of therapies, which may be important to improving initial adoption decisions; or address the requirements of regulatory bodies. Economic evaluation in clinical trials uses a consistent set of data collected within the trial, or by projection from this data, and avoids having to incorporate unrelated (and potentially inconsistent) data from many different sources. This book provides a practical guide to conducting economic evaluation in ongoing clinical trials. It covers issues and techniques related to the collection of both cost and outcome data, as well as a framework for reporting and interpreting economic reports from clinical trials. This is illustrated by detailed supporting examples and exercises, designed to teach the reader how to apply this model.
These exercises are supported with datasets, programmes and solutions made available online. ABOUT THE SERIES - series editors Alastair Gray and Andrew Briggs Economic evaluation of health intervention is a growing specialist field, and this series of practical handbooks tackles, in depth, topics superficially addressed in more geinconsistent economics books. Each volume includes illustrative material, case histories and worked examples to encourage the reader to apply the methods discussed, with supporting material provided online. This series is aimed at health economists in academia, the pharmaceutical industry and the health sector, those on advanced health economics courses, and health researchers in associated fields.
Table of Contents
1. Introduction ; 2. Designing economic evaluations in clinical trials ; 3. Valuing medical service use ; 4. Assessing quality-adjusted life years ; 5. Analyzing cost ; 6. Analyzing censored cost ; 7. Comparing cost and effect: point estimates for cost-effectiveness ratios and net monetary benefit ; 8. Understanding sampling uncertainty: the concepts ; 9. Sampling uncertainty: calculation, sample size and power, and decision criteria ; 10. Evaluating transferability of the results from trials ; 11. Relevance of trial-based economic analyses
Daniel Polsky, Ph.D., is Associate Professor of Medicine, Division of General Internal Medicine, School of Medicine; Associate Professor of Health Care Systems, The Wharton School; Senior Fellow, Leonard Davis Institute of Health Economics; Associate Scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. He received a Ph.D. in Economics from the University of Pennsylvania in May 1996 and a Master of Public Policy from the University of Michigan in 1989. His research areas include health insurance and financial access to health care, economic evaluation of medical and behavioral health interventions, and the health care workforce.