It is 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.
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Henry Glick, Ph.D., is Associate Professor of Medicine, Division of General Internal Medicine, School of Medicine; Associate Professor of Health Care Systems, Wharton School; Senior Fellow, Leonard Davis Institute of Health Economics; Associate Scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. He has 20 years of experience in conducting economic assessments as part of clinical trials and has written and taught extensively about the methods for conducting such assessments. His work covers the spectrum from prospectively designed economic studies in trials to secondary, decision model based, studies. Jalpa A. Doshi, Ph.D., is Research Assistant Professor of Medicine, Division of General Internal Medicine, School of Medicine; Senior Fellow, Leonard Davis Institute of Health Economics; Associate Scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. Her research involves economic and epidemiological assessments of pharmaceuticals using clinical trial and observational databases. She also examines prescription drug access issues and the cost-benefits of improving such access. She teaches methodology courses on cost-effectiveness analyses in clinical trials. Seema S. Sonnad, Ph.D., is Associate Professor, Department of Surgery, School of Medicine; Senior Fellow, Leonard Davis Institute of Health Economics; Associate Scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. She is interested in how individuals and organizations make and implement decisions about new technology and the impact of those decisions on health and economic outcomes. 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.
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