The aim of this review is to evaluate the extent to which Quality of Life (QoL) assessment has been incorporated into clinical oncological trials in the last 15 years. All phase II and III trials published in the Journal of Clinical Oncology, Cancer, The British Journal of Cancer and the European Journal of Cancer during the years 1980, 1985, 1990 and 1995 were reviewed (n = 827). During this period, while the number of studies assessing performance status (PS) increased from 15% in 1980 to 56% in 1995, the number of trials noting a QoL assessment increased only slightly, from 0% in 1980 to 3% in 1995. Moreover, only four of the 13 studies with a QoL evaluation met our criteria for adequate QoL assessment. Thus, despite an increasing interest in QoL, it is still rarely included as an objective in clinical trials, or adequately assessed.
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