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Activity Number: 17 - New Frontiers in Adaptive Clinical Trial Designs
Type: Topic Contributed
Date/Time: Sunday, July 28, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #302906 Presentation
Title: Sample Size Re-Estimation in Action: Design Consideration, Charter Development, and Implementation of Analyzes in a Trial with Survival Endpoints
Author(s): Adam Hamm*
Companies: Cytel, Inc.
Keywords: Sample Size Re-estimation; Adaptive Design

There are many references to the design and analyses of trials that utilize a sample size re-estimation in the literature and practices that should be implemented to maintain trial integrity and provide sponsors with trials that are statistically efficient and cost effective. Our presentation will detail the operational and statistical considerations for a recent trial that utilized sample size re-estimation in a cardiovascular trial with a time to event endpoint. The case study presented in this presentation will detail beneficial study practices and processes that could be improved, including development of the DMC charter to detail adaptive decision making, maintaining the trial masking of treatments, performing complex statistical analyses, and ultimately informing study personnel of decisions made at the interim analysis. The case study will be presented from the unblinded statistician’s point of view, including how the unblinded statistician operates within the clinical team to ensure the best possible outcome for the sponsor at the end of the trial.

Authors who are presenting talks have a * after their name.

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