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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 - #304095
Title: A Case Study of Under-Running
Author(s): Hua Liu*+ and Hongliang Shi and Jing Xu
Companies: Millennium Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc.
Address: 35 Landsdowne Street, Cambridge, MA, 02139, United States
Keywords: under-running ; type I error control ; survival endpoint

For phase III oncology clinical trials with time to event primary endpoint, some studies run into the situation of terminating prior to the design pre-specified number of events. In this case study, we present a real life example of such case. We will show the sponsor's approach on type I error control and sponsor's perspective on interpreting the observed results. We also discuss alternative view on interpreting the results. Results from simulations on different scenarios will be presented to illustrate the situation.

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