The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval

Clin Pharmacol Ther. 2008 Aug;84(2):281-3. doi: 10.1038/clpt.2008.128. Epub 2008 Jun 25.

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.

MeSH terms

  • Device Approval / standards*
  • Drug Approval / methods
  • Humans
  • Outcome Assessment, Health Care / statistics & numerical data*
  • Patient Satisfaction*
  • Quality of Life
  • Reproducibility of Results
  • Surveys and Questionnaires
  • United States
  • United States Food and Drug Administration / trends*