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The efficiency of clinical trial designs for predictive biomarker validation.

Young KY, Laird A, Zhou XH. The efficiency of clinical trial designs for predictive biomarker validation. Clinical trials (London, England). 2010 Oct 1; 7(5):557-66.

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The marker-based strategy designs are less efficient than the traditional design in general. If there is no treatment effect among marker-negative patients, it is still feasible to use the marker-based strategy design I if the assay sensitivity is high. If the treatment effect among marker-negative patients is half of the effect among marker-positive patients, the marker prevalence must be relatively high and the sensitivity of the assay must be very high for the marker-based strategy design I to approximate the efficiency of the traditional design. The efficiency of the marker-based strategy design II relative to the traditional design is low in all scenarios considered under the current study.

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