INTRODUCTION:Health-relatedquality-of-life(HRQL) can be defined as the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being.Health-relatedquality-of-lifemeasures are included in clinical trials of drug treatment to assess the impact of therapy on the patient's functioning. HRQL guidance could allow for use of this data in drug labeling and promotion.OBJECTIVES:The aim of our study was to provide recommendations with respect toregulatoryissuesimportant to the development of guidelines for HRQL research.METHODS:The HRQLworkshopwas planned jointly by members of the Pharmaceutical Research and Manufacturers of AmericaHealthOutcomesCommitteeand the Division of Drug Marketing, Advertising, and Communications of the Food and Drug Administration. Theworkshopwas limited to sixregulatoryissuesrelated to HRQL research in clinical trials of pharmaceutical therapies. These sixissueswere: instrument selection and validation, study design, data analysis, HRQL and safety, clinical meaning, and promotional use. Before the meeting, a consensus was reached that HRQL does not measure, nor should it be used to measure, safety. Therefore, five work groups discussed HRQLissuesand made recommendations.RESULTS:Overall, theworkshoprecommended that HRQL measures be treated as any other clinical end point. Theworkshoprecognized that research in HRQL methods is ongoing and that any guidance should be flexible to allow for changes in this developing research area.CONCLUSIONS:HRQL provides a patient perspective on the impact of disease and therapy on patients' dailylifeand functioning. Including HRQL information in promotion could be beneficial to decision making on the use of therapies. HRQL is a measure of effectiveness, not safety, and should be treated as any other clinical end point.
