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Activity Number: 674 - Adaptive Design - 3
Type: Contributed
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #327215 Presentation
Title: An Adaptive Dose Selection Case Study: Statistical Methods and Operational Considerations
Author(s): Adam Hamm*
Companies: Cytel, Inc.
Keywords: Adaptive; Dose Selection; Clinical Trials

Adaptive designs can improve the efficiency of clinical trials, allowing for an adjustment to the duration of the trial, the endpoint, sample sizes, or elimination/addition of treatment arms. Planning and executing adaptive designs involves statistical and operational challenges. This requires up-front planning and discussion between the statistical team and the client in order to make decisions at the interim analysis, properly analyze data at the interim analysis and end of the trial, and maintain the blind throughout the process. This presentation will discuss some of the common challenges to address when serving as the lead statistician on an adaptive design trial, specifically on a trial with dose selection at the interim analysis, using a case study for discussion.

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

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