FDA Updates Clinical Outcome Assessment Compendium
The FDA has issued an update to its Clinical Outcome Assessment (COA) compendium, which is used as a starting point in early drug development.
The compendium, which hadn’t been updated since the launch of its pilot in January 2016, is recommended to drug developers and researchers when they consider using a COA in clinical trials.
The update expands the original document to include COAs from several new sources, including the labeling of new molecular entity drugs and BLAs approved from 2015 to June 2017.
The compendium organizes and summarizes COAs across many diseases and conditions, describing how certain assessments have been used in clinical trials for measuring patient experiences and in support of labeling claims.