FDA Updates Clinical Endpoint List to Help Others Design Better Clinical Trials 
[Thursday, August 22, 2019]

Since 2016, FDA has been compiling a list of endpoints used in clinical trials used to support NDA applications for drugs. The list called the “Clinical Outcome Assessment (COA) Compendium” organizes all the endpoints used in clinical trials by disease area and product, and includes all endpoints used in NDA and Efficacy Supplements to NDAs. It also separates endpoints used sparingly from those used in multiple programs. This week FDA added a significant update to the list by adding data from 2015-2017. The list is a good beginning for developers or clinical trial design. Although FDA warned that just because an endpoint appears on the list does not mean that it would be acceptable to new drug development programs, the smart money is on the fact that this list was created primarily to help developers use past FDA experiences for new programs. Of course, one need to their homework and not blindly follow the list which is what FDA means.