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Sounding Board

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

List of authors.
  • Rachel E. Sherman, M.D., M.P.H.,
  • Steven A. Anderson, Ph.D., M.P.P.,
  • Gerald J. Dal Pan, M.D., M.H.S.,
  • Gerry W. Gray, Ph.D.,
  • Thomas Gross, M.D., M.P.H.,
  • Nina L. Hunter, Ph.D.,
  • Lisa LaVange, Ph.D.,
  • Danica Marinac-Dabic, M.D., Ph.D.,
  • Peter W. Marks, M.D., Ph.D.,
  • Melissa A. Robb, B.S.N., M.S.,
  • Jeffrey Shuren, M.D., J.D.,
  • Robert Temple, M.D.,
  • Janet Woodcock, M.D.,
  • Lilly Q. Yue, Ph.D.,
  • and Robert M. Califf, M.D.

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.

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Funding and Disclosures

Disclosure forms provided by the authors are available with the full text of this article at

We thank Jonathan McCall, M.S. (Duke Clinical Research Institute, Durham, NC), for editorial assistance with an earlier version of the manuscript.

Author Affiliations

From the Office of the Commissioner (R.E.S., N.L.H., R.M.C.); the Office of Biostatistics and Epidemiology (S.A.A.) and the Office of the Center Director (P.W.M.), Center for Biologics Evaluation and Research; the Office of Surveillance and Epidemiology (G.J.D.P.), the Office of Biostatistics, the Office of Translational Sciences (L.L.), the Office of Medical Policy (M.A.R.), the Office of the Center Director (R.T., J.W.), Center for Drug Evaluation and Research, and the Division of Biostatistics (G.W.G., L.Q.Y.); and the Division of Epidemiology (D.M.-D.), Office of Surveillance and Biometrics (T.G.); and the Office of the Center Director (J.S.), Center for Devices and Radiological Health — all at the Food and Drug Administration, Silver Spring, MD.

Address reprint requests to Ms. Robb at the Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., White Oak, Bldg. 51, Rm. 6346, Silver Spring, MD 20993, or at .

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