A 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 realized by the Patient Focused Medicine Devolepment (PFMD) aims to provide a basis for more meaningful and systematic patient engagement in the development of a COA strategy within clinical trials.
https://pemsuite.org/how-to-guides/
Frequently Asked Questions on Clinical Outcome Assessment (COA): a Food and Drug Administration link
The Food and Drug Administration answers to all your questions Clinical Outcome Assessment (COA) at the following link.
https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions
