![]() The objective of this article is to describe the approaches in a unified framework and highlight their similarities and differences to allow choice of an appropriate methodology by a trialist considering conducting such a trial. In this article, we review the various approaches to seamless phase II/III designs based upon the group-sequential approach, the combination test approach and the adaptive Dunnett method. Seamless learning is an aspiration that aims to remove the seams which hinder the permanency of learning. Methods have gained much attention because of their potential advantages compared to conventional drug development programmes with separate trials for individual phases. The technology used in seamless learning is referred to as a learning hub or a technological interface between learners and learning environments (Looi et al., 2009 Bentley et al., 2010). Such designs allow treatment or dose selection at an interim analysis and comparative evaluation of efficacy with control, in the same study. ![]() ![]() Research into novel trial designs to facilitate this goal has led to, amongst other approaches, the development of methodology for seamless phase II/III designs. In recent years, there has been a drive to save development costs and shorten time-to-market of new therapies. ![]()
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