title: Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D004348:Drug Labeling; D017408:Guidelines as Topic; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010358:Patient Participation; D011788:Quality of Life; D057566:Self Report; D014481:United States; D014486:United States Food and Drug Administration