Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs

被引：76
作者：
Cummings, J. [1 ]
Raynaud, F. [2 ]
Jones, L. [3 ]
Sugar, R. [4 ]
Dive, C. [1 ]
机构：
[1] Univ Manchester, Paterson Inst Canc Res, Manchester M20 4BX, Lancs, England
[2] Inst Canc Res, Canc Res UK Ctr Canc Therapeut, Haddow Labs, Sutton SM2 5NG, Surrey, England
[3] Canc Res UK, Translat Res Team, Clin & Translat Operat & Funding Directorate, London WC2A 3PX, England
[4] Canc Res UK, Drug Dev Off, Clin & Translat Operat & Funding Directorate, London WC2A 3PX, England
来源：
BRITISH JOURNAL OF CANCER | 2010年 / 103卷 / 09期
关键词：
biomarkers; validation; clinical trials; fit-for-purpose; BIOANALYTICAL METHOD VALIDATION; LIGAND-BINDING ASSAYS; CELL-DEATH; CANCER; MACROMOLECULES; STABILITY; QUALITY; SAMPLES;
D O I：
10.1038/sj.bjc.6605910
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the fit-for-purpose approach has recently been developed. This minireview focuses on many of the basic issues surrounding validation of biomarker assays utilised in clinical trials. It also provides an overview on strategies to validate each of the five categories that define the majority of biomarker assays. British Journal of Cancer (2010) 103, 1313-1317. doi: 10.1038/sj.bjc.6605910 www.bjcancer.com Published online 5 October 2010 (C) 2010 Cancer Research UK
引用
收藏
页码：1313 / 1317
页数：5
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