Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference
The FDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpoints, but also improvement on a co-primary measure of functional capacity. The VRFCAT is a computer based virtual-reality measure of functional capacity. Our application for the VRFCAT has officially been accepted into the the FDA’s Clinical Outcome Assessment (COA) Qualification Program. This program is intended to qualify drug development tools that can be relied on the have a specific interpretation in any drug development program and regulatory review. The poster summarizes the progress made to date towards supporting a formal qualification package to the FDA.