In this free webinar, 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. Attendees will gain insights into approaches using blinded sample size re-estimation and approaches using unblinded sample size re-estimation, including the constrained promising zone approach. The featured speakers will discuss how and when to apply these approaches in clinical trial development, as well as the regulatory considerations.
TORONTO, Feb. 28, 2024 /PRNewswire-PRWeb/ -- Attend an informative webinar that explores 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 that 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.
Register for this webinar for a comprehensive exploration of sample size re-estimation and the regulatory considerations in the dynamic landscape of clinical research.
Join experts from Allucent, Lori Davis, PhD, Senior Director, Biostatistics Consulting; and Allan Rosen, MS, Vice President, Biostatistical Consulting, for the live webinar on Wednesday, March 20, 2024, at 1pm EDT (10am PDT).
For more information, or to register for this event, visit Sample Size Re-Estimation: Risk Mitigation at the Planning Stage.
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