Implementation of a Phase 1 Adaptive Clinical Trial in a Treatment of Type 2 Diabetes

Abstract

Phase 1 clinical trials are in general conducted to determine the dose response of a new drug with respect to safety and tolerability (1). There is an increasing interest in reducing the trial time in order to have new and better drugs available to patients in a minimum amount of time. Adaptive designs for dose response have been intensively studied in recent years and have been considered as a novel approach to minimize the number of subjects or patients used in clinical trials and to reduce the risk of serious adverse events. Advantages and disadvantages of this kind of approach have been discussed in the literature and are not an object of discussion for this article (2). However, the implementation of this type of study is still challenging (3–7). This article focuses on the practical advantages of a Bayesian adaptive design and shows how it can be implemented using the R2WinBUGS freely downloadable software.