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Review
. 2015 Apr;12(4):197-212.
doi: 10.1038/nrclinonc.2014.202. Epub 2014 Nov 25.

Pragmatic issues in biomarker evaluation for targeted therapies in cancer

Armand de Gramont  1 , Sarah Watson  2 , Lee M Ellis  3 , Jordi Rodón  4 , Josep Tabernero  4 , Aimery de Gramont  5 , Stanley R Hamilton  6
Affiliations
Review

Pragmatic issues in biomarker evaluation for targeted therapies in cancer

Armand de Gramont et al. Nat Rev Clin Oncol. 2015 Apr.

Abstract

Predictive biomarkers are becoming increasingly important tools in drug development and clinical research. The importance of using both guidelines for specimen acquisition and analytical methods for biomarker measurements that are standardized has become recognized widely as an important issue, which must be addressed in order to provide high-quality, validated assays. Herein, we review the major challenges in biomarker validation processes, including pre-analytical (sample-related), analytical, and post-analytical (data-related) aspects of assay development. Recommendations for improving biomarker assay development and method validation are proposed to facilitate the use of predictive biomarkers in clinical trials and the practice of oncology.

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References

    1. Eur J Cancer. 2013 Dec;49(18):3763-72 - PubMed
    1. Int J Cancer. 1991 Dec 2;49(6):875-9 - PubMed
    1. Mol Pathol. 2003 Jun;56(3):137-40 - PubMed
    1. Eur J Cancer. 1992;28A(6-7):1115-20 - PubMed
    1. Breast Cancer Res Treat. 2012 Apr;132(2):511-21 - PubMed

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