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Clinical Translation of Cancer Biomarkers: Statistical and Epidemiologic Considerations

Outline of Presentation. Surrogate endpoint biomarkers and chemopreventionSEBs and the problem of misclassificationestimating bias due to SEBs; are SEBs feasible/valid?Biomarkers of prognosislack of translation of biomarkers to the clinicmisclassification in biomarker measurementBiomarkers o

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Clinical Translation of Cancer Biomarkers: Statistical and Epidemiologic Considerations

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    1. Clinical Translation of Cancer Biomarkers: Statistical and Epidemiologic Considerations Bruce J. Trock, Ph.D. Johns Hopkins School of Medicine Departments of Urology, Epidemiology, Oncology

    2. Outline of Presentation Surrogate endpoint biomarkers and chemoprevention SEBs and the problem of misclassification estimating bias due to SEBs; are SEBs feasible/valid? Biomarkers of prognosis lack of translation of biomarkers to the clinic misclassification in biomarker measurement Biomarkers of early detection, particularly circulating biomarkers what is clinical significance of “disease” manifested only as abnormal biomarker (“cellular disease”)? how should early detection biomarkers be validated? clinical management of patients with cellular disease?

    3. Surrogate Endpoint Biomarkers and Cancer SEBs decrease sample size and duration in chemoprevention studies Let T=cancer outcome, S=SEB, X=treatment Prentice Criterion: P(T=1 | S,X) = P(T=1 | S) * Other criteria: SEB is in the pathway between treatment & cancer Effect of treatment on SEB is similar to effect on cancer SEB is defined with respect to a specific treatment

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