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

Clinical Pharmacology and Therapeutics

Volumn 84, Issue 2, 2008, Pages 281-283

  Burke, L B ^a   Kennedy, D L ^a   Miskala, P H ^a   Papadopoulos, E J ^a   Trentacosti, A M ^a  

^a Center for Drug Evaluation Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; MEDICAL RECORD; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PATIENT ATTITUDE; PATIENT SAFETY; PATIENT SATISFACTION; PRIORITY JOURNAL; SHORT SURVEY;

DEVICE APPROVAL; DRUG APPROVAL; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 49149121213     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.128     Document Type: Short Survey

References (3)

1. US Food and Drug Administration. Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 〈http://www.fda.gov/cder/guidance/5460dft.pdf〉. Accessed 1 May 2008.
2. US Food and Drug Administration. Draft Guidance for Industry and Review Staff: Target Product Profile - A Strategic Development Process Tool 〈http://www.fda.gov/cder/guidance/6910dft.pdf〉. Accessed 1 May 2008.
3. Cohen, J. Statistical Power Analysis for the Behavioral Sciences 2nd edn., 19-27 (Lawrence Erlbaum Assoc., Hillsdale, NJ, 1988).