ISCTM: Implementing phase 2 dose finding adaptive clinical trials

Abstract

Adaptive clinical trial designs offer significant opportunities to optimize the conduct of clinical trials for the benefit of the subjects in the trial, the subjects that may be treated after the trial and the trial sponsor. However currently, the use of adaptive designs is limited, due to statistical, regulatory and logistical concerns. In this article we share our experience of overcoming the last of these over a range of phase 2, response adaptive, dose finding studies. Based on our experience we feel quite strongly that the logistics of executing adaptive trials should not be a barrier to their use.