Patient-Reported Outcomes (PRO) are outcomes reported directly by trial participants about symptoms, functioning, or quality of life without interpretation by clinicians.
PRO measures are used to capture treatment impact that may not be visible through labs or clinician assessments, such as pain, fatigue, daily functioning, or treatment burden. Standardized PRO instruments support consistent measurement across sites and enable meaningful comparisons between study arms. PRO data can inform labeling claims, benefitñrisk evaluations, and treatment decision-making when collected with validated tools and prespecified analysis plans. Strong PRO implementation improves endpoint credibility by reducing missing data and ensuring participants can complete assessments consistently over time.