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The Evolving Uses of “Real-World” Data

The Evolving Uses of “Real-World” Data Opinion EDITORIAL Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH The terms real-world data (RWD) and real-world evidence (RWE) years earlier and, therefore, identification of more recent pa- have entered the medical lexicon to refer to data sources and tients from real-world cohorts may permit more accurate es- analyses characterizing routine health care delivery. RWD and timation of event rates. Fourth, and perhaps most controversial, is use of RWD to RWE are most often defined by what they are not: information from experiments such as randomized clinical trials. generate so-called synthetic control groups and thereby obvi- Theproliferationofelectronichealthrecords(EHRs)andfast ate the need for randomization. This approach has been em- computershasmadeanalysesofRWDtogenerateRWEbothfea- braced by some drug developers as a means to bring new and sible and relatively inexpensive. For the pharmaceutical indus- effective drugs to market more quickly and at less expense. At try, the potential of this information to accelerate discovery and the same time, using RWD to construct synthetic controls makes product approvals is tantaliz- many statisticians and research methodologists shudder be- ing,andhasspawnedtherapid cause no amount of statistical jiujitsu matches the power of ran- Related article page 1391 growth of companies focused domization to minimize bias and produce valid evidence about http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

The Evolving Uses of “Real-World” Data

JAMA , Volume 321 (14) – Apr 9, 2019

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Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2019.4064
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH The terms real-world data (RWD) and real-world evidence (RWE) years earlier and, therefore, identification of more recent pa- have entered the medical lexicon to refer to data sources and tients from real-world cohorts may permit more accurate es- analyses characterizing routine health care delivery. RWD and timation of event rates. Fourth, and perhaps most controversial, is use of RWD to RWE are most often defined by what they are not: information from experiments such as randomized clinical trials. generate so-called synthetic control groups and thereby obvi- Theproliferationofelectronichealthrecords(EHRs)andfast ate the need for randomization. This approach has been em- computershasmadeanalysesofRWDtogenerateRWEbothfea- braced by some drug developers as a means to bring new and sible and relatively inexpensive. For the pharmaceutical indus- effective drugs to market more quickly and at less expense. At try, the potential of this information to accelerate discovery and the same time, using RWD to construct synthetic controls makes product approvals is tantaliz- many statisticians and research methodologists shudder be- ing,andhasspawnedtherapid cause no amount of statistical jiujitsu matches the power of ran- Related article page 1391 growth of companies focused domization to minimize bias and produce valid evidence about

Journal

JAMAAmerican Medical Association

Published: Apr 9, 2019

References