FDA Publishes Updated Clinical Outcome Assessment Compendium
To encourage the development of clinical outcome assessments (COAs) and their use in clinical trials, the FDA has released an updated version of its COA Compendium.
The compendium explains how certain COAs have been used in clinical trials to gather greater insight on the patient experience and support labeling claims. It also lists those COAs that have been cleared under the agency’s Center for Drug Evaluation and Research’s Drug Development Tool (DDT) Qualification program for potential use in multiple drug development programs. The cleared COAs need no further endorsement from the FDA, however, the approximately 240 other COAs listed in the compendium have not yet been cleared or endorsed by the agency.
Last updated two years ago, this latest iteration includes additional COAs from new molecular entity and biologics license application labels from July 2017 to June 2019, efficacy supplements related to new indications and new populations from July 2017 to June 2018, and more COAs that have been qualified under the DDT program.
Access the new compendium here: https://bit.ly/31PHqnG.