JSM 2005 - Toronto

Abstract #303431

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Activity Number: 192
Type: Contributed
Date/Time: Monday, August 8, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303431
Title: Robust Estimate of Confidence Interval of Treatment Effect
Author(s): Kao-Tai Tsai*+
Companies: Aventis Pharmaceuticals
Address: 34 Baldwin Dr, Berkeley Heights, NJ, 07922, United States
Keywords: Robust estimate ; Clinical trials ; Confidence interval
Abstract:

In typical multicenter clinical trials, it often is necessary to estimate the confidence interval of the treatment effect or other efficacy variables. A straightforward approach is to pool all data and perform the estimation with the normality assumption. However, this approach ignores the variations among the clinical centers and the possibility of nonnormality. In this presentation, we consider the variance components of inter and intracenter variability. Using the approach of generalized confidence interval, we estimate the confidence interval of treatment effect without the normality assumption. The data from a recent clinical trial is used to illustrate the estimation procedure.

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Revised March 2005