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Abstract:
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Most literature for sample size re-estimation focuses on one primary endpoint with normal data. Real clinical trials are much more complex than that and different types of modifications are required to make the 5-zone adaptive design truly useful in practice. For example, for trials with a time-to-event endpoint, we may first adapt total number of patients and then adapt total number of events to minimize both study enrollment time and study follow up time. For trials with multiple primary endpoints, we may need to employ different types of adaptations for different primary endpoints in one single trial. Many complex versions of the 5-zone adaptive design have been implemented in our trials and this presentation will select a few adaptive strategies to illustrate how we adapt the adaptive design to serve the business need in each unique situation. Theoretical proof of the statistical validity of the proposed designs, operational challenges, and strategic decision making process will be discussed. The impact on business including probability of success, development timeline, and cost savings, will also be demonstrated.
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