The Food and Drug Administration (FDA) has published a new Clinical Outcome Assessment (COA) Compendium, intended to serve as a starting point when considering a COA for use in clinical trials. A COA is an assessment of a clinical outcome that can be made via a report by a clinician, a patient, a non-clinician observer or through a performance-based assessment. The COA Compendium is a communication tool and does not represent FDA guidance.

Published: 21 June 2021 21 June 2021