Sequential designs, where trials can stop early based on interim results, are the most widely used type of adaptive design in clinical trials.
Group sequential design is one of the most widely used approaches to designing and analysing sequential trials. However, this class of design has a wide variety of unique theoretical and practical choices that require consideration.
In the second of this two-part webinar series, we discuss the different types of group sequential design and the best approaches for maximising the value of this trial design type.
Sequential designs can greatly reduce the potential cost of a trial by stopping early where evidence is strongly in favour (efficacy) or against (futility) the treatment at an early interim analysis. For example, the accelerated approval of Covid-19 vaccine trials in 2020 were all based on sequential design approaches.
One of the most common approaches to sequential designs is group sequential design. This flexible class of methods allows for a wide range of possible stopping rules while retaining substantial adaptability to deal with post-design deviations at the analysis stage while retaining overall Type I error control - which is vital for regulator approval.
However, a wide variety of methods are included under the group sequential umbrella. One of the most common is the Lan-DeMets error spending approach which allows the Type I alpha (efficacy) and Type II beta (futility) errors to be flexibly assigned to the interim analyses. A large number of possible error spending functions are possible and require careful consideration of the sponsor and regulatory requirements.
Watch this free webinar, as we provide an overview of different types of group sequential design, introduce the concept of error spending and provide guidance on choosing the right method and parameters for your trial.
Duration: 60 minutes
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