title: Ethics and regulatory complexities for pragmatic clinical trials.
authors.affiliation: Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland2Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina4Duke Translational Medicine Institute, Duke University, Durham, North Carolina.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D057186:Comparative Effectiveness Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D019317:Evidence-Based Medicine; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D056687:Off-Label Use; D064792:Pragmatic Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration