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JNCI Journal of the National Cancer Institute 2001 93(14):1039;
© 2001 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 93, No. 14, 1039, July 18, 2001
© 2001 Oxford University Press

IN THIS ISSUE

Guidelines for Biomarker Development

Advancements in laboratory technologies, such as gene-expression microarrays and immunohistochemical methods, have resulted in a proliferation of potential biomarkers to assist in the early detection of cancer. To coordinate research efforts in biomarker development and to promote scientific rigor in their systematic evaluation and use as screening tools, Pepe et al. (p. 1054) present guidelines for clinical testing of biomarkers. They recommend five phases of research, encompassing a hierarchy of levels of evidence. They suggest key components of study design for each phase, and they note that the overall strategy is designed to . . . [Full Text of this Article]

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