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. 2009 Aug 19;101(16):1116-9.
doi: 10.1093/jnci/djp186. Epub 2009 Jul 2.

Improving the biomarker pipeline to develop and evaluate cancer screening tests

Stuart G Baker  1
Affiliations

Improving the biomarker pipeline to develop and evaluate cancer screening tests

Stuart G Baker. J Natl Cancer Inst. .

Abstract

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.

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Figures

Figure 1
Figure 1
Receiver operating characteristic (ROC) curve for hypothetical data, with an optimal slope indicated. The optimal slope of the ROC curve is based on the prevalence of cancer, the cost of a false-positive finding, and the benefit of a true-positive finding (10,11). For identifying biomarkers associated with the early detection of cancer, the optimal slope of the ROC curve is typically steep because the prevalence of cancer is low.
See this image and copyright information in PMC

References

    1. Pepe MS, Etzioni R, Feng ZD, et al. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst. 2001;93(14):1054–1061. - PubMed
    1. Baker SG, Kramer BS, McIntosh M, Patterson BH, Shyr Y, Skates S. Evaluating markers for the early detection of cancer: overview of study designs and methods of analysis. Clin Trials. 2006;3(1):43–56. - PubMed
    1. Baker SG. Identifying combinations of cancer biomarkers for further study as triggers of early intervention. Biometrics. 2000;56(4):1082–1087. - PubMed
    1. The maturing modern. Time. 1956 July 2.
    1. Baker SG, Kramer BS, Srivastava S. Markers for early detection of cancer: statistical issues for nested case-control studies. BMC Med Res Methodol. 2002;2:4. - PMC - PubMed

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