There are many decision points during the process of a product development when the product is experimented in humans. Mostly, starting from Phase 1 (selection of safe and tolerable dose), Phase 2 (proof of concept aiming to obtain preliminary efficacy), and perhaps launching a slightly larger Phase 2b to provide useful information about the product efficacy and safety based on accumulating data. One would use this information to decide whether to launch large scales of Phase 3 trial(s) aiming for registration purposes. In our experiences, attention has been focused mostly on the face values of results from those early studies without considerations other important factors when sponsors designed Phase 3 trials. As a result, we have seen Phase 3 trials terminated early for futility or failed to demonstrate beneficial effect. In this talk, I will present regulatory perspectives regarding issues at early phase product development with examples followed by recommendations.