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 journalReview articleResearchpeer-review

117 Citations (Scopus)


© 2015 Macmillan Publishers Limited. 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 languageEnglish
Pages (from-to)197-212
JournalNature Reviews Clinical Oncology
Issue number4
Publication statusPublished - 28 Apr 2015


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