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Journal of the National Cancer Institute Advance Access published online on July 2, 2009
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djp186
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Published by Oxford University Press 2009.

COMMENTARY

Improving the Biomarker Pipeline to Develop and Evaluate Cancer Screening Tests

Stuart G. Baker

Affiliation of author: Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD

Correspondence to: Stuart G. Baker, ScD, National Cancer Institute, EPN 3131, 6130 Executive Blvd MSC 7354, Bethesda, MD 20892-7354 (e-mail: sb16i{at}nih.gov).

The biomarker pipeline to develop and evaluate cancer screening tests has three stages: identification of promising biomarkers for the early detection of cancer, initial evaluation of biomarkers for cancer screening, and definitive evaluation of biomarkers for cancer screening. Statistical and biological issues to improve this pipeline are discussed. Although various recommendations, such as identifying cases based on clinical symptoms, keeping biomarker tests simple, and adjusting for postscreening noise, have been made previously, they are not widely known. New recommendations include more frequent specimen collection to help identify promising biomarkers and the use of the paired availability design with interval cases (symptomatic cancers detected in the interval after screening) for initial evaluation of biomarkers for cancer screening.

Manuscript received November 25, 2008; revised May 26, 2009; accepted May 29, 2009.


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