title: Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.
authors.affiliation: Center for Drug Development Science, Office of the Associate Dean for Clinical Research, Georgetown University School of Medicine, Washington, USA.
authors.forename: Carl C
authors.initials: CC
authors.lastname: Peck
authors.forename: Donald B
authors.initials: DB
authors.lastname: Rubin
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Sheiner
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D017277:Drug Approval / Q000379:methods*; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers