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Clinical Trials, Vol. 3, No. 6, 538-542 (2006)
DOI: 10.1177/1740774506073108

Cost-effectiveness analyses alongside randomised clinical trials

Alastair M Gray

University of Oxford, Oxford, UK, alastair.gray{at}dphpc.ox.ac.uk

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.


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