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Current Epidemiology Reports

, Volume 4, Issue 4, pp 262–265 | Cite as

Pharmacoepidemiology in the Era of Real-World Evidence

  • Sengwee TohEmail author
Invited Commentary
  • 623 Downloads

Long before the terms real-world data (RWD) and real-world evidence (RWE) were coined, researchers had been using data collected as part of routine healthcare delivery to generate evidence about the utilization, benefits, and risks of medical products [1, 2, 3, 4]. There are several variations to the definitions of RWD and RWE, but most are similar to the ones used by the US Food and Drug Administration (FDA), which defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” and RWE as “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD” [5].

It is not uncommon to re-label an existing construct with a more contemporary descriptor. The term RWD provides a more unified framework to broadly capture the various types of data collected outside of traditional randomized controlled trials. Examples of RWD include electronic health record data,...

Notes

Acknowledgments

Dr. Toh is partially supported by the National Institute of Biomedical Imaging and Bioengineering (U01EB023683).

Compliance with Ethical Standards

Conflict of Interest

Sengwee Toh is a Section Editor for Current Epidemiology Reports.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by the author.

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.Department of Population MedicineHarvard Medical School and Harvard Pilgrim Health Care InstituteBostonUSA

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