[Quality of life measurement: a suitable method for benefit-risk assessment?].

Measurement of health-related quality of life can play a major role in benefit-risk assessment. Preference-based methods for measuring quality of life where data are aggregated into a single quality of life index are particularly well suited for use in quantitative analysis. Using two examples from research on cancer and multiple sclerosis, this paper compares approaches in which quality of life data from genuine studies or from external sources is used. It will be demonstrated that quality of life data can provide relevant information for quantitative benefit-risk assessment in applied research. In addition, quality of life data may be included in more complex approaches of multi-criteria decision analysis.