Biomarker Targeted Randomized Design

Targeted design randomizes only marker positive patients to treatment or control arm. Untargeted design does not measure marker and randomizes all who otherwise are eligible.

Binary Endpoint
Time to Event (Survival) Endpoint

Specify treatment effects for assay negative and assay positive patients
Specify treatment effects for target negative and target positive patients and specify assays sensitivity and specificity

� NIH, 2007