The Role of Patient-Reported Outcomes to Measure Treatment Satisfaction in Drug Development.

Treatment satisfaction is a person's rating of his or her treatment experience, including processes and outcomes. It is directly related to treatment adherence, which may be predictive of treatment effectiveness in clinical and real-world research. Consequently, patient-reported outcome (PRO) instruments have been developed to incorporate patient experience throughout various stages of drug development and routine care. PRO instruments enable clinicians and researchers to evaluate and compare treatment satisfaction data in different clinical settings. It is important to select fit-for-purpose PRO instruments that have demonstrated adequate levels of reliability, validity, and sensitivity to change to support their use. Some of these instruments are unidimensional while some are multidimensional; some are generic and can be applied across different therapeutic areas, while others have been developed for use in a specific treatment modality or condition. This article describes the role of treatment satisfaction in drug development as well as regulatory and Health Technology Assessment (HTA) decision making and calls for more widespread use of carefully selected treatment satisfaction PRO instruments in early- and late-phase drug development.