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Journal of the National Cancer Institute Advance Access originally published online on October 23, 2009
JNCI Journal of the National Cancer Institute 2009 101(21):1453-1463; doi:10.1093/jnci/djp334
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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.

A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment

Sheila E. Taube, Gary M. Clark, Janet E. Dancey, Lisa M. McShane, Caroline C. Sigman, Steven I. Gutman

Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, ArrayBiopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG)

Correspondence to: Sheila E. Taube, PhD, ST-Consulting, PO Box 260, Glen Echo, MD 20812-0260 (e-mail: taubese63{at}alumni.brandeis.edu).

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.

Manuscript received December 30, 2008; revised July 8, 2009; accepted August 26, 2009.


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J Natl Cancer Inst 2009 101: 1435. [Extract] [Full Text] [PDF]





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