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British Journal of Cancer (2010) 103, 1313 1317& 2010 Cancer Research UK All rights reserved 0007 0920/10
http://www.bjcancer.com
Web End =www.bjcancer.com
Minireview
Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
J Cummings*,1, F Raynaud2, L Jones3, R Sugar4 and C Dive1 on behalf of the Bioanalysis and Quality Assurance (BAQA) Group of the ECMC
1Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Wilmslow Road, Manchester M20 4BX, England; 2Cancer Research UK Centre for Cancer Therapeutics, The Institute for Cancer Research, Haddow Laboratories, 15 Cotswold Road, Sutton, Surrey SM2 5N, UK; 3Translational Research Team, Clinical and Translational Operations and Funding Directorate, Cancer Research UK, 61 Lincolns Inn Fields, London WC2A 3PX, UK; 4The Drug Development Office, Clinical and Translational Operations and Funding Directorate, Cancer Research UK, 61 Lincolns Inn Fields, London WC2A 3PX, UK
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, 13131317. doi:http://dx.doi.org/10.1038/sj.bjc.6605910
Web End =10.1038/sj.bjc.6605910 http://www.bjcancer.com
Web End =www.bjcancer.com Published online 5 October 2010& 2010 Cancer Research UK
Keywords: biomarkers; validation; clinical trials; fit-for-purpose
During anticancer drug development, biomarkers can have many applications. They may be utilised as discovery tools, as pharmacodynamic (PD) markers of drug mechanism or efficacy both preclinically and in early phase trials, and as predictive indices of patient response in late phase trials (Lee et al, 2005; Sarker and Workman, 2007). Thus, incorporation of biomarkers into clinical trials has the potential to guide and accelerate the pace of development of new anticancer drugs (McShane et al, 2009). Biomarkers may also provide a diagnostic readout on tumour biology in experimental cancer medicine or be prognostic or predictive of disease or therapeutic outcome (Ludwig and Weinstein, 2005). However, at present there are few fully qualified biomarkers available to utilise...