A nonparametric test for proving noninferiority in clinical trials with ordered categorical data

Ullrich Munzel; Dieter Hauschke

doi:10.1002/pst.17

journal article Jan 01, 2003

A nonparametric test for proving noninferiority in clinical trials with ordered categorical data

Ullrich Munzel Dieter Hauschke

Pharmaceutical Statistics Vol. 2 No. 1 pp. 31-37 · Wiley

View at Publisher Save 10.1002/pst.17

Abstract

AbstractWe consider the problem of proving noninferiority when the comparison is based on ordered categorical data. We apply a rank test based on the Wilcoxon–Mann–Whitney effect where the asymptotic variance is estimated consistently under the alternative and a small‐sample approximation is given. We give the associated 100(1−α)% confidence interval and propose a formula for sample size determination. Finally, we illustrate the procedure and possible choices of the noninferiority margin using data from a clinical trial. Copyright © 2003 John Wiley & Sons, Ltd.

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References

Details

Published: Jan 01, 2003
Vol/Issue: 2(1)
Pages: 31-37
License: View

Authors

Cite This Article

Ullrich Munzel, Dieter Hauschke (2003). A nonparametric test for proving noninferiority in clinical trials with ordered categorical data. Pharmaceutical Statistics, 2(1), 31-37. https://doi.org/10.1002/pst.17

A nonparametric test for proving noninferiority in clinical trials with ordered categorical data

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