Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels

Value Health. 2012 May;15(3):401-3. doi: 10.1016/j.jval.2012.03.1385.
No abstract available

Publication types

  • Editorial

MeSH terms

  • Clinical Trials as Topic / methods*
  • Drug Labeling*
  • Guidelines as Topic*
  • Humans
  • Outcome Assessment, Health Care / methods*
  • Patient Participation*
  • Quality of Life
  • Self Report
  • United States
  • United States Food and Drug Administration*