Some Practical Considerations in the Implementation of Adaptive Clinical Trials in Pharmaceutical Development Programs
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*Dennis W King, STATKING Clinical Services 

Keywords: Adaptive Trials

Adaptive designs have received much attention in the statistical literature and are being more commonly employed in drug development programs. While the application of these designs is theoretically sound, there are many practical considerations that must be considered before implementing these designs in practice. In this presentation, we will examine some of the components that are key in the execution of adaptive designs. Two examples will be covered: a Phase I study of a laser treatment for brain tumors and a Phase III study adaptive design with an interim analysis that involved potential stopping for futility or superiority as well as a sample size re-estimation for continuation of the trial.