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

被引：71

作者：

Burke, L. B. ^{[1
]}

Kennedy, D. L. ^{[1
]}

Miskala, P. H. ^{[1
]}

Papadopoulos, E. J. ^{[1
]}

Trentacosti, A. M. ^{[1
]}

机构：

[1] US FDA, Res, Ctr Drug Evaluat, Off New Drugs,Study Endpoints & Label Dev, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2008年 / 84卷 / 02期

关键词：

D O I：

10.1038/clpt.2008.128

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：281 / 283

页数：3