Adaptive Designs and Multiple Testing Procedures

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Adaptive designs are a way to improve the efficiency and participant benefit of clinical trials. With an adaptive design, information gathered during the trial can be used to change the design in a statistically robust way. There are many types of adaptive designs that are possible for different situations in all phases of trials. In both adaptive and non-adaptive trials, there are often multiple hypotheses being tested. Examples include trials with multiple endpoints, multiple treatment arms and when a trial tests a treatment in different patient subgroups. Adaptive trials often mean that a particular hypothesis is tested several times during the trial. This creates issues with multiple testing, for which suitable procedures are needed to ensure the appropriate error rate is controlled.

Participants will learn about a variety of new adaptive clinical trial designs, including group-sequential, multi-arm multi-stage (MAMS), sample size re-estimation, amongst others. As well as learning about how to design adaptive trials we will cover the implications of the design on the analysis and practical aspects of running the trial.

Throughout the course, real examples will be used to demonstrate the methodology. There will be a strong emphasis on learning how to use available software (in both R and Stata depending on the preference of the delegate) to implement the methodology in practice.