Patient-reported outcomes and health-related quality of life in effectiveness studies: Pros and cons
Marquis, P.; Arnould, B.; Acquadro, C.; Roberts, W.M.rk
Drug Development Research 67(3): 193-201
The importance of patient perspectives on disease impact and response to therapy is increasingly recognized. Patient-reported outcomes (PROs), including health-related quality of life (HRQL), provide information on the effectiveness of medical interventions that cannot be obtained using objective clinical measures. For drug development, PROs such as symptom questionnaires are accepted by the European Medicines Agency (EMEA) and US Food and Drug Administration (FDA) in the approval process.