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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.
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.