Assessment of quality of life in clinical trials of the British Medical Research Council.

This article describes aspects of the way the Cancer Therapy Committee of the British Medical Research Council incorporates quality-of-life (QOL) assessments in randomized clinical trials in patients with cancer. The steps taken in incorporating QOL assessments in individual trial protocols are described. The aspects described concern problems associated with choice of instruments, time of assessment, sample size, and analysis. A protocol for patients with small-cell lung cancer that compares oral etoposide with intravenous multidrug chemotherapy is used for illustration.