Health-related quality-of-life assessment and planning for the pharmaceutical industry.

Health-related quality of life (HRQL) represents a patient-centered approach to assessing functional status and well-being that integrates the impact of both medical treatment and disease. The pharmaceutical industry is increasingly incorporating HRQL measures into the drug development process as part of a comprehensive outcomes evaluation. HRQL measures can be used to distinguish the effects of competing treatments, demonstrate trade-offs between survival and functional status and well-being, and provide comprehensive information on the effects of treatment on patient outcomes. Two main approaches have been used to measure HRQL: psychometric-based instruments and preference-based instruments. Each approach has advantages and disadvantages for the evaluation of pharmaceuticals, and no one approach can be recommended for all studies. The selection of HRQL measures for clinical trials requires attention to the appropriateness, psychometric characteristics, and practicality of the available instruments. The comprehensive evaluation of pharmaceutical treatments requires measures of HRQL as well as safety and clinical efficacy.