Curr Epidemiol Rep (2017) 4:262–265 https://doi.org/10.1007/s40471-017-0123-y INVITED COMMENTARY Sengwee Toh Published online: 19 October 2017 Springer International Publishing AG 2017 Long before the terms real-world data (RWD) and real-world . In other words, RWE generated from observational stud- evidence (RWE) were coined, researchers had been using data ies or pragmatic trials that leverage routinely collected elec- collected as part of routine healthcare delivery to generate tronic health data may soon be used to supplement findings evidence about the utilization, benefits, and risks of medical from traditional randomized controlled trials in the approval of medical products [8, 9]. Safety findings from post- products [1–4]. There are several variations to the definitions of RWD and RWE, but most are similar to the ones used by marketing RWD-based studies, which have been more formal- the US Food and Drug Administration (FDA), which defines ly integrated into regulatory review in the USA recently , RWD as “data relating to patient health status and/or the de- maygainadditional regulatory importance. livery of health care routinely collected from a variety of It will be interesting to see how regulatory agencies and the sources” and RWE as “the clinical evidence regarding the research community react and position
Current Epidemiology Reports – Springer Journals
Published: Oct 19, 2017
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