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May 16, 2019

Real-world Evidence—What Does It Really Mean?

Author Affiliations
  • 1Aptitude Health, Atlanta, Georgia
  • 2Cardinal Health Specialty Solutions, Cardinal Health, Dublin, Ohio
  • 3Department of Medicine, Oregon Health and Science University, Portland
JAMA Oncol. Published online May 16, 2019. doi:10.1001/jamaoncol.2019.0450

Much has been written about real-world evidence (RWE) in scientific papers and the lay media. Although some researchers and journalists tout its value, opponents are vocal in challenging its validity, pointing out shortcomings and downplaying any potential benefits. Despite an emphasis on the importance of RWE in the 21st Century Cures Act, a standard definition of the term has not been uniformly embraced.1 The US Food and Drug Administration defines RWE as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.”2,3 In addition, the agency’s Real-world Evidence Program framework defines real-world data (RWD) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.”4(p4) To maximize the potential of RWE and define its role moving forward, limitations must be balanced with merits when considering RWD sources (Table).

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