An outcome measure based on a report that comes directly from the patient (e.g., study subject) about the status of the patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s responses.
- FDA-Patient-Focused Drug Development Glossary: https://www.fda.gov/drugs/development-approval-process-drugs/patient-focused-drug-development-glossary
