The U.S. Food and Drug Administration (FDA) defines real-world evidence (RWE) as the clinical evidence derived from the use of a treatment or other medical product from analyzing real-world data (RWD).~1 These data are generated from many different study designs and analyses. The use of RWD has become a lot more popular with the increased use of digital databases such as electronic health records (EHR) and the implementation of technology such as Apple Inc.'s HealthKit. In the past, RWD was used solely to monitor post-market safety and adverse events, but recently has been included to support submissions for approval ahead of commercialization. Beyond regulatory uses, RWD and RWE also are used to support coverage decisions by healthcare insurance companies as well for guidelines and decision support tools.
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