Abstract
Adaptive designs for clinical trials have the potential to improve the efficiency of clinical research by, for instance, seamlessly combining different stages of a clinical development programme.
Highlights
Adaptive designs for clinical trials have the potential to improve the efficiency of clinical research by, for instance, seamlessly combining different stages of a clinical development programme
The work required to develop application specific software for each new trial is a potential barrier to the more extensive use of Adaptive seamless designs (ASD), as simulation studies are often required at the planning stage to explore a range of options prior to deciding on an appropriate design
A number of common analysis methods and simulation tools for assessing the performance of a number of design options, are available in some widely used commercial packages, but currently no free software exists for planning and simulation of ASD
Summary
Adaptive designs for clinical trials have the potential to improve the efficiency of clinical research by, for instance, seamlessly combining different stages of a clinical development programme. Adaptive seamless designs (ASD) combining phases II and III with adaptations such as treatment or subgroup selection are becoming increasingly widely used.
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