Patient-Reported Outcome (PRO)
A health outcome directly reported by the patient without interpretation by a clinician. PROs capture the patient's perspective on symptoms, functional status, and quality of life. They are increasingly important secondary endpoints in peptide drug trials, particularly for weight management and chronic disease.
Technical Context
PRO instruments must be validated (demonstrating reliability, validity, and responsiveness to change) for the specific population and condition. FDA PRO guidance (2009) established standards for PRO instrument development and qualification. Common PROs in peptide drug trials: IWQOL-Lite-CT (Impact of Weight on Quality of Life — Clinical Trials version, for obesity), SF-36 (general health status), EQ-5D (health utility for cost-effectiveness), WPAI (Work Productivity and Activity Impairment), and condition-specific instruments (e.g. FACT for cancer). PRO data capture increasingly uses electronic systems (ePRO) via smartphones or tablets, improving data quality and reducing missing data compared to paper questionnaires. PRO data can support label claims if based on pre-specified, well-powered analyses.