JSM 2005 Online Program

Abstract #303749

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	487
Type:	Contributed
Date/Time:	Thursday, August 11, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #303749
Title:	Nonproportional Hazards in Sequential Trials
Author(s):	Qi Jiang*+ and Steven Snapinn
Companies:	Amgen, Inc. and Amgen, Inc.
Address:	One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, United States
Keywords:	Nonproportional hazards ; Lag ; Noncompliance ; Power ; Sequential Tirals ; Futility
Abstract:	Clinical endpoint trials typically are designed and analyzed under the assumption of proportional hazards. However, there often are reasons to suspect the hazard rates may not be proportional. Two common scenarios include the possibility of onset lag (i.e., a delay between the time treatment begins and the time the treatment is fully effective) and noncompliance (i.e., a loss of effect over time as more patients stop taking the study therapy). While statistical methods exist for the calculation of sample size and the analysis of standard endpoint trials with nonproportional hazards, the impact of nonproportional hazards on the properties of sequential clinical trials has not been well studied. Specific questions to be addressed include does onset lag increase the probability of stopping early for futility? If so, to what degree does this decrease power? How does the impact of noncompliance on power differ between standard and sequential trials?

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