Economic evaluation and quality of life assessments in cancer clinical trials: the CHART Trial.

Arguments are being made more frequently to incorporate economic evaluations and quality of life assessments into clinical trials. Using a randomised, multicentre, phase 3 cancer clinical trial as an example, this paper outlines the importance of including such assessments; the practical considerations associated with the design of such trials; the methods for collecting such data; and, how such data can be used. Finally, it is emphasised that the anticipated benefits of collecting data relating to resource use and quality of life should outweigh the associated costs to research funding organisations.