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Originally published as JCO Early Release 10.1200/JCO.2005.02.8712 on September 6 2005

Journal of Clinical Oncology, Vol 23, No 29 (October 10), 2005: pp. 7332-7341
© 2005 American Society of Clinical Oncology.
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REVIEW ARTICLE

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers

Richard Simon

From the Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD

Address reprint requests to Richard Simon, DSc, National Cancer Institute, 9000 Rockville Pike, MSC 7434, Bethesda, MD 20892; e-mail: rsimon{at}nih.gov.

Oncologists need improved tools for selecting treatments for individual patients. The development of therapeutically relevant prognostic markers has traditionally been slowed by poor study design, inconsistent findings, and lack of proper validation studies. Microarray expression profiling provides an exciting new technology for relating tumor gene expression to patient outcome, but it also provides increased challenges for translating initial research findings into robust diagnostics that benefit patients and physicians in therapeutic decision making. This article attempts to clarify some of the misconceptions about the development and validation of multigene expression signature classifiers and highlights the steps needed to move genomic signatures into clinical application as therapeutically relevant and robust diagnostics.

Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.

Author's disclosures of potential conflicts of interest are found at the end of this article.




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