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  • Feature ArticlesFeature Articles

    A military-civilian perspective on real-world evidence to support regulatory decision making

    This article summarizes the framework promoting the collection and analysis of real-world data (RWD) in the healthcare system. The authors emphasize how the US Military Health System (MHS) used 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 appr...