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Activity Number: 308 - Adaptive Design - 2
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330054 Presentation
Title: Complexity of Implementing Sample Size Re-Estimation (SSR) in Oncology Trials
Author(s): Alicia Zhang* and Yuqi Chen and Chris Holland
Companies: Amgen and Amgen and Amgen
Keywords: Sample size re-estimation; probability of success; operating characteristics; group sequential design

Sample size re-estimation (SSR) allows a trial to change sample size based on interim results using a pre-specified criteria. It provides an opportunity to increase probability of successful trial in case that treatment shows trend of efficacy at interims, but underpowered with original sample size. In this presentation, we will review statistical methods to implement SSR, use simulations to show operating characteristics, and compare SSR with classical group sequential design. We will also present simulation results in a more complicated design where there are two endpoints and both allow SSR at interim analysis. Operational challenges of applying SSR will also be discussed.

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

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