Clinical outcome assessment
A clinical outcome assessment (COA) measures the change in a clinical outcome. For example, a clinical endpoint of a clinical trial studying a new therapy may be reducing the number of hospitalizations for respiratory distress. In this case, the clinical outcome is hospitalizations for respiratory distress. The COA will be the tool used to quantify the number of hospitalizations for respiratory distress for each participant of the study.
Types of COAs include:
• Patient-reported outcome (PRO) measures
• Clinician-reported outcome (ClinRO) measures
• Observer-reported outcome (ObsRO) measures
• Performance outcome (PerfO) measures
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
Glossary from “BEST (Biomarkers, EndpointS, and other Tools) Resource” [Internet].
NCATS Toolkit for Patient-Focused Therapy Development: Clinical Outcome Assessments
U.S. Food and Drug Administration (FDA): Clinical Outcome Assessment (COA): Frequently Asked Questions