title: Real-World Evidence - What Is It and What Can It Tell Us?
authors.affiliation: 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.
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Sherman
authors.affiliation: 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.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Anderson
authors.affiliation: 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.
authors.forename: Gerald J
authors.initials: GJ
authors.lastname: Dal Pan
authors.affiliation: 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.
authors.forename: Gerry W
authors.initials: GW
authors.lastname: Gray
authors.affiliation: 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.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gross
authors.affiliation: 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.
authors.forename: Nina L
authors.initials: NL
authors.lastname: Hunter
authors.affiliation: 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.
authors.forename: Lisa
authors.initials: L
authors.lastname: LaVange
authors.affiliation: 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.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: 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.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Marks
authors.affiliation: 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.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Robb
authors.affiliation: 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.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Shuren
authors.affiliation: 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.
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.affiliation: 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.
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.affiliation: 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.
authors.forename: Lilly Q
authors.initials: LQ
authors.lastname: Yue
authors.affiliation: 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.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D055317:Evidence-Based Practice; D033161:Government Regulation; D006801:Humans; D064887:Observational Studies as Topic / Q000379:methods; D011306:Prescription Fees / Q000331:legislation & jurisprudence*; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration