title: Trial evidence and approval of therapeutic agents.
authors.affiliation: SDG LLC, Cambridge, Massachusetts.
authors.forename: Allan M
authors.initials: AM
authors.lastname: Green
authors.affiliation: SDG LLC, Cambridge, Massachusetts.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
mesh_terms: D017277:Drug Approval; D016032:Randomized Controlled Trials as Topic; D014486:United States Food and Drug Administration