Real-World Evidence — What Is It and What Can It Tell Us?

20161,992 citationsJournal Article

Authors

Rachel E. Sherman · Center for Biologics Evaluation and Research

Steven A. Anderson · Center for Biologics Evaluation and Research

Gerald J. Dal Pan · Center for Drug Evaluation and Research

Gerry Gray · Center for Devices and Radiological Health

Thomas P. Gross · Center for Devices and Radiological Health

Nina L. Hunter · Center for Biologics Evaluation and Research

Lisa M. LaVange

Abstract

The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.

Topics & Keywords

Health Systems, Economic Evaluations, Quality of Life Health Sciences Research and Education Pharmaceutical Economics and Policy

Publication Details

Published in: New England Journal of Medicine

Volume 375, Issue 23, pp. 2293-2297

DOI: 10.1056/nejmsb1609216

Field-Weighted Citation Impact: 624.15

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Real-World Evidence — What Is It and What Can It Tell Us?

Authors

Abstract

Topics & Keywords

Publication Details