Pragmatic issues in biomarker evaluation for targeted therapies in cancer

Armand De Gramont; Sarah Watson; Lee M. Ellis; Jordi Rodón; Josep Tabernero; Aimery De Gramont; Stanley R. Hamilton

doi:10.1038/nrclinonc.2014.202

Pragmatic issues in biomarker evaluation for targeted therapies in cancer

Armand De Gramont, Sarah Watson, Lee M. Ellis, Jordi Rodón, Josep Tabernero, Aimery De Gramont, Stanley R. Hamilton

Research output: Contribution to journal › Review article › peer-review

135 Scopus citations

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.

Original language	English (US)
Pages (from-to)	197-212
Number of pages	16
Journal	Nature Reviews Clinical Oncology
Volume	12
Issue number	4
DOIs	https://doi.org/10.1038/nrclinonc.2014.202
State	Published - Apr 28 2015

ASJC Scopus subject areas

Oncology

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AU - De Gramont, Aimery

AU - Hamilton, Stanley R.

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Pragmatic issues in biomarker evaluation for targeted therapies in cancer

Abstract

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