Online Program

Recent Advancements and Applications of 2-in-1 Design (302420)

*Cong Chen, Merck & Co., Inc. 

Keywords: oncology, intermediate endpoint

The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for the adaptive decision. Under a mild assumption that is expected to generally hold in practice, both the Phase 2 trial (in case of no expansion) and the Phase 3 trial (in case of expansion) can be tested at the full alpha level without inflating the overall Type I error of the study. Due to its flexibility and robustness, the design has quickly generated a lot of interest since its recent publication.

This talk presents recent advancements in statistical research and applications in practice.