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BACKGROUND: Many health economists increasingly advocate the use of model-based evaluations rather than trial-based evaluations. PURPOSE: The purpose of this paper is to review the merits and limitations of RCT-based evaluations of cost-effectiveness. RESULTS: The paper draws on the examples of large studies such as the United Kingdom Prospective Diabetes Study and the Heart Protection Study to suggest that large randomised trials offer a number of advantages to health economists wishing to estimate cost-effectiveness, including access to patient-level data, unbiased estimates of resource use as well as effects, the estimation of cost-effectiveness in sub-groups of patients, and an enhanced ability to build and validate extrapolation models. CONCLUSIONS: While many methodological issues remain to be resolved, the use of patient-level data derived from clinical trials as a basis for economic evaluations is likely to remain an important part of the health economics evidence base, and will also continue to provide the data required for methodological research.

Original publication

DOI

10.1177/1740774506073108

Type

Journal

Clin Trials

Publication Date

2006

Volume

3

Pages

538 - 542

Keywords

Cost-Benefit Analysis, Economics, Pharmaceutical, Humans, Models, Economic, Quality of Life, Randomized Controlled Trials as Topic, Research Design