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.
Funding and Disclosures
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
We thank Jonathan McCall, M.S. (Duke Clinical Research Institute, Durham, NC), for editorial assistance with an earlier version of the manuscript.
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