title: Cost-effectiveness analyses alongside randomised clinical trials.
abstract: 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.
authors.affiliation: Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford, UK. alastair.gray@dphpc.ox.ac.uk
authors.forename: Alastair M
authors.initials: AM
authors.lastname: Gray
mesh_terms: 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