Cost-effectiveness analyses alongside randomised clinical trials.
BACKGROUND
Many health economists increasingly advocate the use of model-based evaluations rather than trial-based evaluations.


OBJECTIVE
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.
Gray
Alastair M
AM
Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford, UK. alastair.gray@dphpc.ox.ac.uk
D003362:Cost-Benefit Analysis; D017850:Economics, Pharmaceutical / Q000706:statistics & numerical data*; D006801:Humans; D018803:Models, Economic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design