Statistical and Practical Considerations for Clinical Evaluation of Predictive Biomarkers

被引：104

作者：

Polley, Mei-Yin C. ^{[1
]}

Freidlin, Boris ^{[1
]}

Korn, Edward L. ^{[1
]}

Conley, Barbara A. ^{[2
]}

Abrams, Jeffrey S. ^{[3
]}

McShane, Lisa M. ^{[1
]}

机构：

[1] NCI, Biometr Res Branch, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA

[2] NCI, Canc Diag Program, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA

[3] NCI, Canc Treatment & Evaluat Program, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA

来源：

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE | 2013年 / 105卷 / 22期

关键词：

CELL LUNG-CANCER; RANDOMIZED PHASE-III; ADJUVANT TEMOZOLOMIDE; MAINTENANCE THERAPY; DESIGN; CETUXIMAB; EGFR; CHEMOTHERAPY; RADIOTHERAPY; CONCOMITANT;

D O I：

10.1093/jnci/djt282

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Predictive biomarkers to guide therapy for cancer patients are a cornerstone of precision medicine. Discussed herein are considerations regarding the design and interpretation of such predictive biomarker studies. These considerations are important for both planning and interpreting prospective studies and for using specimens collected from completed randomized clinical trials. Specific issues addressed are differentiation between qualitative and quantitative predictive effects, challenges due to sample size requirements for predictive biomarker assessment, and consideration of additional factors relevant to clinical utility assessment, such as toxicity and cost of new therapies as well as costs and potential morbidities associated with routine use of biomarker-based tests.

引用

页码：1677 / 1683

页数：7

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