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

Departament de Medicina

Producció científica: Contribució a revista › Article de revisió › Recerca › Avaluat per experts

141 Cites (Scopus)

Resum

© 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.

Idioma original	Anglès
Pàgines (de-a)	197-212
Revista	Nature Reviews Clinical Oncology
Volum	12
Número	4
DOIs	https://doi.org/10.1038/nrclinonc.2014.202
Estat de la publicació	Publicada - 28 d’abr. 2015

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10.1038/nrclinonc.2014.202

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abstract = "{\textcopyright} 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.",

author = "{De Gramont}, Armand and Sarah Watson and Ellis, {Lee M.} and Jordi Rod{\'o}n and Josep Tabernero and {De Gramont}, Aimery and Hamilton, {Stanley R.}",

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doi = "10.1038/nrclinonc.2014.202",

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T1 - Pragmatic issues in biomarker evaluation for targeted therapies in cancer

AU - De Gramont, Armand

AU - Watson, Sarah

AU - Ellis, Lee M.

AU - Rodón, Jordi

AU - Tabernero, Josep

AU - De Gramont, Aimery

AU - Hamilton, Stanley R.

PY - 2015/4/28

Y1 - 2015/4/28

N2 - © 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.

AB - © 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.

U2 - 10.1038/nrclinonc.2014.202

DO - 10.1038/nrclinonc.2014.202

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JO - Nature Reviews Clinical Oncology

JF - Nature Reviews Clinical Oncology

IS - 4

ER -

Pragmatic issues in biomarker evaluation for targeted therapies in cancer

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