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Journal of Biopharmaceutical Statistics Volume 31, 2021 - Issue 6
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Research Article

Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials

Samvel B. Gasparyana Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, SwedenCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-4797-2208
ORCID Icon,
Elaine K. Kowalewskib Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USAORCID Iconhttps://orcid.org/0000-0002-7915-877X
ORCID Icon,
Folke Folkvaljona Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
,
Olof Bengtssona Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
,
Joan Buenconsejoc Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, USAORCID Iconhttps://orcid.org/0000-0003-4514-2208
ORCID Icon,
John Adlera Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
&
Gary G. Kochb Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA
 show all
Pages 765-787 | Published online: 23 Sep 2021
 
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ABSTRACT

The win odds is a distribution-free method of comparing locations of distributions of two independent random variables. Introduced as a method for analyzing hierarchical composite endpoints, it is well suited to be used in the analysis of ordinal scale endpoints in COVID-19 clinical trials. For a single outcome, we provide power and sample size calculation formulas for the win odds test. We also provide an implementation of the win odds analysis method for a single ordinal outcome in a commonly used statistical software to make the win odds analysis fully reproducible.

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