Discover an informative webinar to explore the intricacies of sample size re-estimation in clinical trials and how assumptions around treatment effects, endpoint variability, and practical considerations impact trial success. The planned sample size for a clinical trial involves several assumptions around expected treatment effects and endpoint variability as well as practical considerations. At the trial design stage, these assumptions may be made without highly reliable data thereby putting the success of the trial at risk.
To mitigate risk, an interim analysis with a reassessment of sample size is a practical solution. This procedure may be reasonably straightforward if there is only uncertainty about endpoint variability which typically allows for a blinded interim analysis to reassess sample size without requiring an alpha adjustment. When there is uncertainty about the effect size or there are practical reasons to intentionally plan the study, to begin with an optimistic effect size, there are unblinded approaches to inspect the treatment effect and adjust the sample size at the time of interim analysis.
What you will learn
- Approaches using blinded sample size re-estimation
- Approaches using unblinded sample size re-estimation, including the Constrained Promising Zone approach
- How and when to apply these approaches in clinical trial development
- Regulatory considerations
Watch this webinar for a comprehensive exploration of sample size re-estimation and the regulatory considerations in the dynamic landscape of clinical research.
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