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
Listen to this webinar for a comprehensive exploration of sample size re-estimation and the regulatory considerations in the dynamic landscape of clinical research.
About the Presenters
Lori Davis, PhD – Senior Director, Biostatistics Consulting
Dr. Lori Davis has more than 20 years of professional experience in biostatistics. In her current position as Senior Director of Biostatistics Consulting at Allucent, she is responsible for the internal development of biostatistical methodology as well as client involvement providing consulting for scientific strategy toward clinical trial design, execution and reporting. She is also responsible for regulatory body interactions on an ongoing basis for her clients.
Dr. Davis has developed effective leadership in directing biostatistical strategies across an array of therapeutic areas and indications. She particularly enjoys working closely with her clients and aims to become an integral part of ‘the team’. Lori holds a PhD in Biostatistics from the University of Toronto and an MSc in Mathematics and Statistics from Queen’s University.
Vanessa Beddo, PhD – Vice President, Biostatistical Consulting
Vanessa Beddo regularly provides innovative and complex study design solutions in support of efficiently navigated regulatory paths, building on her 15+ years of experience in clinical trial design and analysis. As VP of Biostatistical Consulting at Allucent, she is also responsible for regulatory body interactions on an ongoing basis throughout program lifecycles on behalf of her clients. Prior to this role, Dr. Beddo served in various management positions involving oversight of statistical/programming staff and leadership with respect to departmental initiatives, processes, and training. Her expertise also includes clinical development of pharmaceuticals and biologics, having served as the lead statistician on Phase I-IV clinical trials and drug submissions leading to successful drug approvals.
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