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# Clinical Outcome Assessment Compendium Updated
- URL: https://www.fdaweb.com/clinical-outcome-assessment-compendium-updated/
- Published: 2021-12-08T12:00:00.000Z
- Updated: 2026-09-14T17:24:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150726

FDA says it has released an updated version of the Clinical Outcome Assessment (COA) Compendium to encourage the development and implementation of patient-focused clinical outcome assessments in clinical trials to support drug approvals and labeling claims. The agency says the [compendium](https://www.fda.gov/drugs/development-resources/clinical-outcome-assessment-compendium?ref=fdaweb.com) is a communications tool that organizes and summarizes COA information for many different diseases and conditions into a single resource. The compendium is intended to be used as a starting point when considering how COAs might be used in clinical trials, FDA says, adding that it will likely be most informative early in drug development.

FDA says: 

- The updated COA compendium is an extension of the previously updated document published in 2019 and includes additional COAs from NME and BLA labels from 7/2017 to 6/2019, efficacy supplements on new indications and new populations from 7/2017 to 6/2018, and qualified measures based on CDER’s COA DDT (drug development tool) qualification program;
- The drug’s name and approval date corresponding to the labeling from which the COA was extracted is included in the updated compendium; and
- The update does not refer to COAs in development or under review within the DDT program because they have not received full FDA review and qualification for the proposed use and may not yet be publicly available.