The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.
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.
Burke
L B
LB
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
Kennedy
D L
DL
Miskala
P H
PH
Papadopoulos
E J
EJ
Trentacosti
A M
AM
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*