Home 9 Glossary Item 9 Clinical Outcomes Assessment (COA)

Clinical Outcomes Assessment (COA)

clinical outcome assessment (COA) is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include:

  • Patient-reported outcome (PRO) measures
  • Observer-reported outcome (OBsRO) measures
  • Clinician-reported outcome (ClinRO) measures
  • Performance outcome (PerfO) measures

These assessments are essential for understanding the impact of medical treatments on patients’ lives and wellbeing. They help healthcare providers and researchers make informed decisions about patient care and new therapies.

FDA-Food and Drug Administration. Clinical Outcome Assessment (COA): Frequently Asked Questions
https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions

To go in depth

A guide in the development of COA strategy

This “How-to” Guide aims to provide a basis for more meaningful and systematic patient engagement in the development of a COA strategy within clinical trials.

https://www.evidera.com/what-we-do/patient-centered-research/patient-engagement-clinical-outcome-assessment-guide/

Frequently Asked Questions on Clinical Outcome Assessment (COA): a Food and Drug Administration link

https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions

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