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The Patient‐Reported Outcome (PRO) Consortium: Filling Measurement Gaps for PRO End Points to Support Labeling Claims
Author(s) -
Coons S J,
Kothari S,
Monz B U,
Burke L B
Publication year - 2011
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.2011.203
Subject(s) - clinical pharmacology , outcome (game theory) , clinical trial , medical physics , medicine , intensive care medicine , psychology , pharmacology , pathology , mathematics , mathematical economics
The importance of appropriately and effectively incorporating the patient's voice into the evaluation of new medical products has been recognized and affirmed by regulators. 1 , 2 , 3 Patient‐reported outcomes (PROs) are increasingly being assessed in clinical trials to quantify treatment benefits such as symptom relief and improved functioning. Translating PRO‐based treatment benefits into labeling claims can provide information to physicians and patients and assist in prescribing decisions. 4 , 5 Hence, standardizing the valid and reliable measurement of PRO end points is critical. Clinical Pharmacology & Therapeutics (2011); 90 5, 743–748. doi: 10.1038/clpt.2011.203