HEALTH-RELATED QUALITY-OF-LIFE ASSESSMENT AND PLANNING FOR THE PHARMACEUTICAL-INDUSTRY

Health-related quality of life (HRQL) represents a patient-centered ap proach to assessing functional status and well-being that integrates t he impact of both medical treatment and disease. The pharmaceutical in dustry is increasingly incorporating HRQL measures into the drug devel opment process as part of a comprehensive outcomes evaluation. HRQL me asures can be used to distinguish the effects of competing treatments, demonstrate trade-offs between survival and functional status and wel l-being, and provide comprehensive information on the effects of treat ment on patient outcomes. Two main approaches have been used to measur e HRQL: psychometric-based instruments and preference-based instrument s. Each approach has advantages and disadvantages for the evaluation o f pharmaceuticals, and no one approach can be recommended for all stud ies. The selection of HRQL measures for clinical trials requires atten tion to the appropriateness, psychometric characteristics, and practic ality of the available instruments. The comprehensive evaluation of ph armaceutical treatments requires measures of HRQL as well as safety an d clinical efficacy.