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Abstract Details

Activity Number: 319
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304815
Title: Statistical Issues in Over-Running or Under-Running Clinical Trials
Author(s): Jing Xu and Bin Zhang*+
Companies: Millennium Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc.
Address: 35 Landsdowne Street, Cambridge, MA, 02139,
Keywords: overrunning ; underrunning ; group sequential clinical trials ; type I error

In group sequential clinical trial, sometime the trials continue even though the pre-specified boundary for stopping was crossed. In some other cased, trials had to be terminated or abandoned before stopping rules can be fulfilled for various reasons. We investigate the statistical properties of these situations under different scenarios, and investigate ways to preserve type I error in these situations.

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