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The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.
Burke, L B; Kennedy, D L; Miskala, P H; Papadopoulos, E J; Trentacosti, A M.
Affiliation
  • Burke 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
Clin Pharmacol Ther ; 84(2): 281-3, 2008 Aug.
Article in En | MEDLINE | ID: mdl-18580868
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.
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Full text: 1 Database: MEDLINE Main subject: United States Food and Drug Administration / Patient Satisfaction / Outcome Assessment, Health Care / Device Approval Limits: Humans Country/Region as subject: America do norte Language: En Year: 2008 Type: Article
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Full text: 1 Database: MEDLINE Main subject: United States Food and Drug Administration / Patient Satisfaction / Outcome Assessment, Health Care / Device Approval Limits: Humans Country/Region as subject: America do norte Language: En Year: 2008 Type: Article