PROs: defining clinical benefit from the patient's perspective. Draft guidance provides direction in evaluating patient-reported outcomes.
Pazdur
Richard
R
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration Rockville, Maryland, USA.
D017408:Guidelines as Topic; D006801:Humans; D017060:Patient Satisfaction; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012649:Self Concept; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration