Commentary on "Applying CHW method to 2-in-1 design: gain or lose".

ABSTRACT

While 2-in-1 designs give a flexibility to make a clinical trial either an information generation Phase 2 trial or a full scale confirmatory Phase 3 trial, flexible sample size designs can naturally fit into the 2-in-1 design framework. This study is to show that the CHW design can be blended into a 2-in-1 design to improve the adaptive performance of the design. Commenting on the usual 2-in-1 design, we demonstrated that the CHW design can achieve the goal of a 2-in-1 design with satisfactory statistical power and efficient average sample size for a targeted range of the treatment effect.