A Military-Civilian Perspective on Real-World Evidence to Support Regulatory Decision Making

This article summarizes how the US Military Health System (MHS) used real-world data (RWD) during the Iraq and Afghanistan Wars to achieve historic rates of survival and describe a new era of collaboration between the US Department of Defense (DoD) and the US Food and Drug Administration (FDA). The article reviews the FDA evidentiary standards for medical product approval and gives examples of how RWE can help meet those standards.

The authors state, ” Now, more than ever, it is important for civilian health systems, federal programs, and industry to recognize and invest in this ecosystem to improve efficiency of medical product development and advance patient care.”

(Source:  Regulatory Focus, Rasmussen and Young, July 29, 2020)