FDA Updates Clinical Outcome Assessment Compendium (COA Compendium)

FDA Updates Clinical Outcome Assessment Compendium (COA Compendium) 

The U.S Food and Drug Administration (FDA) released the updated version of the Clinical Outcome Assessment Compendium (COA Compendium) to encourage the development and implementation of patient-focused clinical outcome assessments (COAs) in clinical trials to support drug approvals and labeling claims.

The COA Compendium is a communication tool that organizes and summarizes COA information for many different diseases and conditions into a single resource. FDA hopes this will facilitate communication with industry and researchers and provide clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development. 

• The newly released COA Compendium is an extension of the original document (pilot COA compendium) and includes additional COAs from the following major sources: NME and BLA labels from 2015 to June 2017, efficacy supplements pertaining to new indication and new population from first and second quarter (January to June) of 2017 and qualified measures based on CDER's COA DDT qualification program. The COA Compendium was also updated based on the public’s request for the drug labeling source of the COAs.
• The drug’s name and approval date corresponding to the labeling from which the COA was extracted is included in the updated Compendium document. Clinical and COA Staff reviews are available publicly for many of these drugs on the internet in the Drugs@FDA database if further information is desired.
• The COA Compendium update will not refer to COAs in development or under review within FDA’s DDT Qualification program, because these instruments have not received full FDA review and qualification for the proposed use and may not yet be publicly available. Ongoing qualification projects are listed separately on the public COA Qualification website. This reflects the transparency provision of the 21st Century Cures Act.
• The COA Compendium is intended to be an evolving resource. The FDA will periodically update the Compendium such that information regarding COAs from the most recently approved drugs’ labeling, as well as those recently qualified, will be captured with each update.

For more information, visit the COA Compendium website. You may also submit your questions/inquiries to COACompendium@fda.hhs.gov.