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- 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