The U.S. Food and Drug Administration (FDA) is working to develop a roadmap for the implementation of real-world evidence (RWE) into the drug development arena, and as part of that effort released a framework for assessing its potential uses.
According to a BioCentury report, the framework makes mention of using data collected from electronic health records, observational and pragmatic studies, as well as generating actionable information through mobile or wearable devices.
In a statement released Dec. 6, 2018, FDA Commissioner Scott Gottlieb described RWE as a “top strategic priority for the FDA.”
“RWE provides us with a potential source of information that can complement, augment and expand our understanding of how best to use medical products — improving what we know about our medical care,” Gottlieb says.
To read the FDA’s framework on RWE, click here.