clinical outcome assessment
- Guideline or reference source
- FDAPNG Patient network glossary terms
- Definition
- A COA is any assessment that may be influenced by human choices, judgment, or motivation and may support either direct or indirect evidence of treatment benefit. Unlike biomarkers that rely completely on an automated process or algorithm, COAs depend on the implementation, interpretation, and reporting from a patient, a clinician, or an observer. The four types of COAs are patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures.
- Abbreviation for
- COA
- Related Term
- clinical outcome assessment qualification
- concept of interest
- context of use, clinical outcome assessment
- drug development tool
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