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The Use of Patient‐Reported Outcome Measures in the Evaluation of Medical Products for Regulatory Approval
Author(s) -
Burke LB,
Kennedy DL,
Miskala PH,
Papadopoulos EJ,
Trentacosti AM
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.128
Subject(s) - clinical pharmacology , outcome (game theory) , perspective (graphical) , medicine , function (biology) , clinical trial , alternative medicine , psychology , intensive care medicine , family medicine , pharmacology , computer science , pathology , mathematics , mathematical economics , artificial intelligence , evolutionary biology , biology
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. Clinical Pharmacology & Therapeutics (2008); 84 , 2, 281–283 doi: 10.1038/clpt.2008.128