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Activity Number: 416 - Clinical Trial Design- 4
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329278
Title: ESTIMATION of SD for a LOG-TRANSFORMED VARIABLE BASED on SUMMARY STATISTICS in the ORIGINAL SCALE
Author(s): Hui Quan* and Juan Zhang and Deborah Dukovic and Dongli Zhou
Companies: Sanofi and Sanofi and Sanofi and Merck Senoro
Keywords: Lognormal distribution; Confidence interval; Inter-Quartile Range; Asymptotic distribution
Abstract:

Clinical study endpoints, including some biomarkers, are frequently analyzed after a log transformation. To calculate study power for detecting a between-treatment difference in the log scale, an estimate of the standard deviation of the log-transformed variable is needed. Often, though, only summary statistics in the original scale including arithmetic means with corresponding standard deviations or sample medians and inter-quartile ranges are found in the literature. In the absence of individual subjects' log-transformed data for directly calculating the sample standard deviation in the log scale, alternative approaches should be applied. This paper presents methods for estimating the standard deviation of a log-transformed variable via the arithmetic means and standard deviations or medians and inter-quartile ranges of the untransformed variable. It further presents methods for constructing the corresponding confidence intervals. A meta-analysis approach, combining data from all sources for more robust estimation, is also discussed. Simulations and examples are provided to assess the performances of these estimates.


Authors who are presenting talks have a * after their name.

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