title: Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.
abstract: Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.). robert.mentz@duke.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Berdan
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Tyrus
authors.initials: T
authors.lastname: Rorick
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Emily C
authors.initials: EC
authors.lastname: O'Brien
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Jenny C
authors.initials: JC
authors.lastname: Ibarra
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.affiliation: From Duke Clinical Research Institute, Durham, NC (R.J.M., A.F.H., L.G.B., T.R., E.C.O'B., J.C.I., L.H.C., E.D.P.); and Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC (R.J.M., AF.H., E.C.O'B., E.D.P.).
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards
keywords: clinical protocols; clinical trial; ethics; pragmatic clinical trial