Features - Population enrichment design for survival endpoint
East now offers users the ability to simulate a population enrichment design with a survival endpoint. This design starts out by enrolling subjects from a full population, which consists of a subpopulation of interest and its complement. East allows the user to perform an interim analysis and decide whether to continue enrolment in both subpopulations with or without sample size re-estimation, only continue enrolment from the subpopulation of interest, or terminate the trial for futility.
- Seamless phase 2/3 with Phase 2 objective to select the right patient population and Phase 3 to confirm the effect in the selected population
- Allows adaptation in sample size and patient population
- Mitigate risk of uncertainty around treatment effect and patient population
- Precision medicine to target the right treatment for the right patient population