Quality-of-life end points in oncology drug trials

被引:0
作者
Beitz, J [1 ]
机构
[1] US FDA, Div Oncol Drug Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
来源
ONCOLOGY-NEW YORK | 1999年 / 13卷 / 10期
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中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Health-related quality of life (HRQL) is a multidimensional construct that represents the patient's perspective oil valued aspects of health and functioning. Over the last several years, the pharmaceutical industry, as well as health care providers and the patient advocacy community, have shown increasing interest in HRQL as an outcome measure. Pharmaceutical companies and other sponsors of cancer clinical trials are seeking novel approaches with which to establish the benefits of treatment and to differentiate their products from other marketed products. Health care providers hope to provide cancer patients with therapies that positively affect their quality of life. To date, however, most oncology drug approvals have been based on traditional end points, such as survival and tumor response rate. This article will focus on some of the lessons learned from recent reviews of HRQL data and will describe some of the many challenges that lie ahead.
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页码:1439 / 1442
页数:4
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