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April 9, 2019

The Evolving Uses of “Real-World” Data

Author Affiliations
  • 1University of North Carolina at Chapel Hill
  • 2Associate Editor, JAMA
  • 3Dana-Farber Cancer Institute, Boston, Massachusetts
JAMA. 2019;321(14):1359-1360. doi:10.1001/jama.2019.4064

The terms real-world data (RWD) and real-world evidence (RWE) have entered the medical lexicon to refer to data sources and analyses characterizing routine health care delivery.1 RWD and RWE are most often defined by what they are not: information from experiments such as randomized clinical trials.

The proliferation of electronic health records (EHRs) and fast computers has made analyses of RWD to generate RWE both feasible and relatively inexpensive. For the pharmaceutical industry, the potential of this information to accelerate discovery and product approvals is tantalizing, and has spawned the rapid growth of companies focused on using EHR data for this purpose. This includes Flatiron Health, the sponsor of the study by Singal and colleagues2 published in this issue of JAMA. The frenzy of interest in RWD has also been fueled by the Food and Drug Administration (FDA) signaling receptiveness to consider these data sources in regulatory review,3 and recent publication of a framework for doing so.4