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This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 199
Type: Contributed
Date/Time: Monday, July 30, 2007 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308284
Title: The Impact of Proportional Hazards Assumption on the Late Onset Survival Data
Author(s): Guoguang Ma*+ and Kathy Harris
Companies: Amgen Inc. and Amgen Inc.
Address: 1120 Veterans Blvd, South San Francisco, CA, 94080,
Keywords: survival analysis ; proportional hazards assumption ; Cox model ; log-rank test ; clinical trials
Abstract:

The log-rank and Cox tests are powerful under the assumption of proportional hazards that the relative risk remains constant over time. While these tests can be well powered to detect some differences between treatment groups that do not satisfy the assumption, they can have poor power to detect differences when cumulative incidence curves that are initially equal but later diverge or that initially diverge but later approach one another. This issue is usually raised in the analysis of clinical trials data when an investigational drug has a delayed treatment effect. In this work, we evaluate the impact of the proportional hazards assumption on the late onset survival data through simulation studies where we assume exponential distributions for the survival time and uniform distributions for the dropout time. The log-rank and Cox tests are also compared to the logistic regression model.


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Revised September, 2007