Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit

Authored by: William E. Barlow

Handbook of Statistics in Clinical Oncology

Print publication date:  March  2012
Online publication date:  March  2012

Print ISBN: 9781439862001
eBook ISBN: 9781439862018
Adobe ISBN:


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Biologic markers are commonly used as prognostic indicators of outcome following a diagnosis of disease and subsequent treatment. In oncology, tumor-based markers are used to suggest the potential for cancer to recur or to cause death. These markers are regarded as “prognostic” in that they provide information to patients about what they might expect in the future, but the markers may not help choose appropriate treatment (Schumacher et al., 2006). On the other hand, “predictive” markers do suggest that a particular therapy is optimal and may reflect that the prognostic effect of the marker differs by treatment or that the efficacy of a particular treatment depends on the marker. The distinction between prognostic and predictive factors is usually attributed to the late William McGuire (McGuire et al., 1992). Marker discovery begins by noting the important prognostic effect of a marker, which may in turn be found to be predictive upon greater examination of the prognostic effect conditional on different treatment choices. Ideally, treatment has been randomized, thus providing an unbiased assessment of predictive ability of a marker with regard to treatment choice.

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