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P Fayers, R Hays. Oxford University Press, 2005.
Health related quality of life is increasingly used as an end point in clinical trials. Particularly, in diseases with a poor prognosis such as metastatic cancer, quality of life may be of major concern. However, clinicians are still reluctant to accept quality of life as an end point equivalent to more “objective” end points such as size of the tumour as assessed by imaging or disease free survival in patients with cancer. Having to deal with practical and time consuming issues such as randomisation, informed consent, and the organisation of study medication when enrolling …