Robust designs in non-inferiority three arm clinical trials with presence of heteroscedasticity
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Date
2007-07-13T12:28:32Z
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Abstract
In this paper, we describe an adjusted method to facilitate a non-inferiority trial by a three-arm robust
design. Because local optimal designs derived in Hasler et al. [2007] require knowledge about the ratios of
the population variances and are not necessarily robust with respect to possible misspecifications, a maximin
approach is adopted. This method requires only the specification of an interval for the of variance ratios
and yields robust and efficient designs. We demonstrate that a maximin optimal design only depends on the
boundary points specified for the intervals of the variance ratios and receive numerical and analytical solutions.
The derived designs are robust and very efficient for statistical analysis in non inferiority three arm trials.
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Keywords
Gold design trials, Maximin design, Non-inferiority, Randomized clinical trial, Robust design, Three arm design