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Activity Number: 522
Type: Contributed
Date/Time: Thursday, August 7, 2008 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302531
Title: Permutation Test Approach To Compare Two Groups of Censored Lognormal Data with Multiple Detection Limits
Author(s): Wei Zhong*+ and Jeffrey Welge and Linda Levin and Paul Succop and Rakesh Shukla
Companies: ICON Clinical Research and University of Cincinnati and University of Cincinnati and University of Cincinnati and University of Cincinnati
Address: , , 95134,
Keywords: Lognormal ; Permutation Test ; MLE-EM ; Type I Error Rate ; Power
Abstract:

Censored lognormal data with multiple lower detection limits frequently arise in safety laboratory assessment. A common practice to compare the means between two groups of such data is to perform the two sample t-test on the log-transformed outcome and to report the resulting P-values for the null hypothesis based on the original data. The problem with such a practice is that it essentially tests the equality between the two group medians. The permutation test approach with the mean estimation obtained from the MLE-EM algorithm was studied in this paper. The proposed method was evaluated through a series of simulation studies and its performance was compared to the two sample t-test and Z-score test. Simulation results consistently showed that the proposed approach provides the minimum Type I error rates and maximum power.


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