Abstract #301249

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JSM 2003 Abstract #301249
Activity Number: 302
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301249
Title: Adjusting for Center Effects in Multicenter Survival Data Analysis
Author(s): Shibao Feng*+ and Robert A. Wolfe
Companies: University of Michigan and University of Michigan
Address: 1413 McIntyre St., Ann Arbor, MI, 48105-2410,
Keywords: clinical trial ; center effects ; observational study ; survival analysis ; stratification ; frailty model
Abstract:

In multicenter clinical trials and observational studies, the type of patients and quality of management can vary from center to center. For time to event data, several methods have been applied to adjust for the center effects, which include treating center effects as fixed or random, and stratifying on centers. In this manuscript, the statistical properties of these methods are discussed and compared by using a simulation study. We conclude that the fixed effects approach may be applied under the conditions where the number of events in each center is large and the treatment effect is independent of the center effects. However, in observational studies, treatment effect is often correlated with center effects. Under this situation, stratification methods can be applied to yield cobsistent treatment effect estimate. The asymptotic properties of the stratification approach depend on the total number of events occurring in the sample. If the censoring rate is high, which leads to a small sample problem, the treatment effect could be overestimated. Moreover, a random effects approach can be employed if there are a large number of centers enrolled in the study.


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