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Patient-reported outcome (PRO) - FACILITATE

Patient-reported outcome (PRO)

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

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