Drug Safety

, Volume 41, Issue 12, pp 1309–1312 | Cite as

Real World Evidence: Time for a Switch?

  • Rachel E. Sobel
  • Andrew BateEmail author
  • Robert F. Reynolds

Real World Evidence (RWE) provides critical information about the performance of medicines in routine clinical practice, as actually prescribed by physicians and taken by patients. For decades, observational designs and electronic healthcare databases have been used to characterize patient populations, describe the natural history of diseases, assess postapproval safety and conduct risk management programs as part of the drug development lifecycle. These approaches have evolved in recent years due to advances in electronic data collection, data linkage, computing power, the greater availability of analytic tools and methodologies, and established best practices. The US FDA Sentinel Initiative illustrates these advances well by rapidly generating evidence (in days, not months) in large populations (more than half of the US population in some analyses) and with increased transparency [1]. These advances have made possible the potential use of these systems for outcomes other than...


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Conflicts of interest

Rachel E. Sobel, Andrew Bate, and Robert F. Reynolds are employees and shareholders of Pfizer, which manufactures both generic and branded medicines. The views expressed in this paper are those of the authors and may not necessarily reflect the views or opinions of Pfizer.


No sources of funding were used to assist in the preparation of this commentary.


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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Pfizer Inc, Worldwide Safety and RegulatoryNew YorkUSA
  2. 2.Pfizer Ltd, Worldwide Safety and RegulatoryWalton OaksUK

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