title: The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.
abstract: Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient's response by a clinician or anyone else.
authors.affiliation: Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation, Research, Food and Drug Administration, Silver Spring, Maryland, USA. Laurie.burke@fda.hhs.gov
authors.forename: L B
authors.initials: LB
authors.lastname: Burke
authors.forename: D L
authors.initials: DL
authors.lastname: Kennedy
authors.forename: P H
authors.initials: PH
authors.lastname: Miskala
authors.forename: E J
authors.initials: EJ
authors.lastname: Papadopoulos
authors.forename: A M
authors.initials: AM
authors.lastname: Trentacosti
mesh_terms: D018795:Device Approval / Q000592:standards*; D017277:Drug Approval / Q000379:methods; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D017060:Patient Satisfaction; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*