Abstract
For most patients with non-small cell lung cancer, maintaining or improving the quality of their remaining life may be as (or more) important than a small extension of survival. Thus, the assessment of quality of life should be a key component of treatment trials to inform future clinical decision-making. However, only a small percentage of randomized trials in non-small cell lung cancer have included quality of life and many of these may be criticized for poor design, inadequate sample size and/or complex analyses. A radical rethink over the way in which quality of life is included in trials is required. Much larger sample sizes, predefined quality of life hypotheses, innovative methods to improve compliance rates and standard methods of analysis are required. Until trialists begin to take note of these messages, information on quality of life from trials will continue to be largely distrusted and disregarded by doctors and patients.