Economic Analysis in Clinical Trials: Practical Considerations
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Drug Informarion Journal, Vol. 33, pp. 1053-1060, 1999 Printed in the USA. All rights reserved.
ECONOMIC ANALYSIS IN CLINICAL TRIALS: PRACTICAL CONSIDERATIONS ANDREW M. BAKER,MPA Directormeam Leader, Outcomes Management Strategies, Pfizer Pharmaceuticals Group, Pfizer Inc, New York, New York
R E N ~J.E GOLDBERG ARNOLD,PHARMD President, Pharmacon International, Inc. Center for Pharmacoeconomic Studies, New York, New York, Clinical Associate Professor, Arnold and Marie Schwartz College of Pharmacy and Allied Health Sciences, Brooklyn, New York, and Clinical Associate Professor, Albany College of Pharmacy, Albany, New York
DIANAJ. KANIECKI,PHARMD Executive Vice President, Pharmacon International, Inc. Center for Pharmacoeconomic Studies, New York, New York, and Clinical Associate Professor, Rutgers University College of Pharmacy, Piscataway, New Jersey
The article addresses several important issues in the measurement of medical resource utilization or direct medical costs when incorporating such measurements into clinical trials. One of the most important issues faced by the analyst relates to the high internal validity of randomized, controlled trials, which require protocol-driven experiences that may falsely increase or decrease costs. The technique of modeling, which will require judgments on the level of detail to include in clinical pathways, can be employed in the identification of costs. Other important issues include attribution of costs to disease or treatment and assignment of monetary values. Sources of cost data, reimbursement coding systems, and resource valuation data sources in the United States are described. Finally, the trade-offs inherent in including economic evaluations in Phase III clinical trials are addressed and specific guidelines for performing economic evaluations in clinical trials are provided. Key Words: Resource; Utilization; Valuation; Economic; Trials
INTRODUCTION HOW DOES ONE VALUE resources in the United States and assure that the method will hold up in Germany? What are some of the advantages and pitfalls of valuing resources from randomized clinical trials (RCTs)? Does one include all resources or just a select few? How does the audience to whom the
Based on a presentation at the DIA Workshop “CostEffectiveness Analysis: Measures and Methods in Clinical Trials,” November 10-1 1, 1994, Orlando, Florida. Reprint address: Andrew M. Baker, MPA, Pfizer Inc, 235 East 42nd Street, New York, NY 10017-5755.
economic valuation is addressed influence the analysis? These are just a few of the concerns of those involved in measuring resource use in clinical trials. The goal of researchers conducting socioeconomic evaluations is to identify and compare the “opportunity costs” of health care interventions (ie, the value of foregone alternatives once a particular intervention has been selected) (1). Comparing opportunity costs is difficult in practice, however, because it requires that all to a particular strategY be included in the analysis. It requires inClUSi0n not Only Of medical item
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