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Statistical Methods in Medical Research
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Economic endpoints in clinical trials

John Cook

Merck Research Laboratories, Blue Bell, PA, USA, john_cook{at}merck.com

Michael Drummond

Centre for Health Economics, University of York, York, UK

Joseph F Heyse

Merck Research Laboratories, Blue Bell, PA, USA

Healthcare decision makers are increasingly requesting information on the cost and cost-effectiveness of new medicines at the time of product launch. In order to provide this information, data on healthcare resource utilization and, in some cases, costs, may be collected in clinical trials. In this paper, we discuss some of the issues statisticians need to address when it is appropriate to include these economic endpoints in the trial. Several design issues are discussed, including the alternative types of and methods for collecting economic endpoint data, sample size and generalizability. Alternative approaches in the analysis of resource utilization, cost and cost-effectiveness are also presented. Finally, several of the analytic approaches are applied to actual data from a clinical trial.

Statistical Methods in Medical Research, Vol. 13, No. 2, 157-176 (2004)
DOI: 10.1191/0962280204sm359ra
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