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We show that this method yields an exaggerated P value and overestimates the prognostic impact of the biomarker. We illustrate that the degree of the optimistic bias increases with the number of variables being considered in a risk model. Finally, we discuss methods to appropriately ascertain the additional prognostic contribution of the new biomarker in disease settings where standard prognostic factors already exist. Throughout the article, we use real examples in oncology to highlight relevant methodologic issues, and when appropriat
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