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A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment
A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment. Participants agreed that critical decision points in the product life cycle depend...
Autores principales: | , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2009
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773185/ https://www.ncbi.nlm.nih.gov/pubmed/19855077 http://dx.doi.org/10.1093/jnci/djp334 |
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author | Taube, Sheila E. Clark, Gary M. Dancey, Janet E. McShane, Lisa M. Sigman, Caroline C. Gutman, Steven I. |
author_facet | Taube, Sheila E. Clark, Gary M. Dancey, Janet E. McShane, Lisa M. Sigman, Caroline C. Gutman, Steven I. |
author_sort | Taube, Sheila E. |
collection | PubMed |
description | A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment. Participants agreed that critical decision points in the product life cycle depend on the level of understanding of the biology of the target and its interaction with the drug, the preanalytical and analytical factors affecting biomarker assay performance, and the clinical disease process. The more known about the biology and the greater the strength of association between an analytical signal and clinical result, the more efficient and less risky the development process will be. Rapid entry into clinical practice will only be achieved by using a rigorous scientific approach, including careful specimen collection and standardized and quality-controlled data collection. Early interaction with appropriate regulatory bodies will ensure studies are appropriately designed and biomarker test performance is well characterized. |
format | Text |
id | pubmed-2773185 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-27731852009-11-05 A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment Taube, Sheila E. Clark, Gary M. Dancey, Janet E. McShane, Lisa M. Sigman, Caroline C. Gutman, Steven I. J Natl Cancer Inst Commentaries A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment. Participants agreed that critical decision points in the product life cycle depend on the level of understanding of the biology of the target and its interaction with the drug, the preanalytical and analytical factors affecting biomarker assay performance, and the clinical disease process. The more known about the biology and the greater the strength of association between an analytical signal and clinical result, the more efficient and less risky the development process will be. Rapid entry into clinical practice will only be achieved by using a rigorous scientific approach, including careful specimen collection and standardized and quality-controlled data collection. Early interaction with appropriate regulatory bodies will ensure studies are appropriately designed and biomarker test performance is well characterized. Oxford University Press 2009-11-04 2009-11-04 /pmc/articles/PMC2773185/ /pubmed/19855077 http://dx.doi.org/10.1093/jnci/djp334 Text en Published by Oxford University Press 2009. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Commentaries Taube, Sheila E. Clark, Gary M. Dancey, Janet E. McShane, Lisa M. Sigman, Caroline C. Gutman, Steven I. A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title | A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title_full | A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title_fullStr | A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title_full_unstemmed | A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title_short | A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment |
title_sort | perspective on challenges and issues in biomarker development and drug and biomarker codevelopment |
topic | Commentaries |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773185/ https://www.ncbi.nlm.nih.gov/pubmed/19855077 http://dx.doi.org/10.1093/jnci/djp334 |
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