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Abstract:
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The landscape of clinical research is rapidly changing with boundaries between development phases dissolving, master protocols facilitating broader developments focussing not only on a single treatment or single disease, and study designs becoming more flexible through applications of adaptive designs. Adaptive seamless designs combine aspects of learning and confirming, which are associated with phases 2 and 3 of clinical development programmes, in a single trial. These include treatment or dose selection as well as subgroup selection (also known as enrichment). In practical applications adaptations are often informed by short-term outcomes, since no or insufficient information on the longer-term primary outcome is available at the time of the interim analysis. In this presentation, we present adaptive seamless designs with treatment or subgroup selection. Specifically, we will comment on a framework for optimal designs and will comment on computational aspects included efficient simulations. The approaches will be motivated and illustrated by clinical trials in a variety of disease areas.
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