Title

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

Authors

Cui, Lu; Hung, H.M. James; Wang, Sue Jane

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.

Subjects

CLINICAL trials; EXPERIMENTAL design

Publication

Journal of Biopharmaceutical Statistics, 2019, Vol 29, Issue 4, p722

ISSN

1054-3406

Publication type

Academic Journal

DOI

10.1080/10543406.2019.1634088