Ther Innov Regul Sci. 2022 Oct 26. doi: 10.1007/s43441-022-00471-4. Online ahead of print.
The two trials paradigm plays a prominent role in drug development and has been widely and controversially discussed. Its purpose is to ensure replicability or substantiation of study results. This note investigates a simple generalization of the paradigm to more than two trials that preserves the project wise type-I error rate and power.