The Patient-Reported Outcome (PRO) Consortium: Filling Measurement Gaps for PRO End Points to Support Labeling Claims

被引：45

作者：

Coons, S. J. ^{[1
]}

Kothari, S. ^{[2
]}

Monz, B. U. ^{[3
]}

Burke, L. B. ^{[4
]}

机构：

[1] Crit Path Inst, Patient Reported Outcome Consortium, Tucson, AZ USA

[2] Astellas Pharma US Inc, Hlth Econ & Outcomes Res, Deerfield, IL USA

[3] Boehringer Ingelheim GmbH & Co KG, Global Hlth Econ & Outcomes Res, Ingelheim, Germany

[4] US FDA, Off New Drugs, Ctr Drug Evaluat Res, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2011年 / 90卷 / 05期

关键词：

CLINICAL-TRIALS; SELECTION; VALIDITY; EXAMPLE;

D O I：

10.1038/clpt.2011.203

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.(1-3) 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.

引用

页码：743 / 748

页数：6

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