Drug Information Update- FDA Releases the Pilot Version of the Clinical Outcome Assessment Compendium (COA Compendium) for public comment

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Today FDA released the pilot 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 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.

FDA is seeking public feedback on the utility of the COA Compendium, the approach for development of the Compendium, and any suggestions for future approaches and expansion of the document. Comments to the docket will be accepted until March 13, 2016.

FDA will also host a webinar to review the compendium and answer any questions and will update stakeholders with details when available. For more information visit the COA Compendium website. You may also submit your questions/inquiries to COACompendium@fda.hhs.gov.