JSM 2011 Online Program

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Abstract Details

Activity Number: 365
Type: Roundtables
Date/Time: Tuesday, August 2, 2011 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302639
Title: Statistical Issues in Futility Analyses
Author(s): Xuan Liu*+
Companies: Merck & Co., Inc.
Address: , , ,
Keywords: futility analysis ; power ; sample size re-estimation
Abstract:

Futility analysis has been used widely in randomized clinical trials. It is not uncommon that the experimental medicine fails to demonstrate benefit versus standard treatment. In these situations, it may be plausible to stop the trial early to reduce the exposure to inefficacious treatment for patients from an ethical stand point and save resource for more promising compounds from a business stand point. In this session we will discuss issues related to the futility analysis including how to select the futility boundary and timing of the futility analyses, and the corresponding impact on the power, and sample size re-estimation.


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