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Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials.
Gasparyan, Samvel B; Kowalewski, Elaine K; Folkvaljon, Folke; Bengtsson, Olof; Buenconsejo, Joan; Adler, John; Koch, Gary G.
Affiliation
  • Gasparyan SB; Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Kowalewski EK; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA.
  • Folkvaljon F; Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Bengtsson O; Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Buenconsejo J; Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, USA.
  • Adler J; Biometrics, Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Koch GG; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA.
J Biopharm Stat ; 31(6): 765-787, 2021 11 02.
Article in En | MEDLINE | ID: mdl-34551682
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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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: COVID-19 Limits: Humans Language: En Journal: J Biopharm Stat Journal subject: FARMACOLOGIA Year: 2021 Document type: Article Affiliation country:
Fulltext
Add to My VHL
Print
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: COVID-19 Limits: Humans Language: En Journal: J Biopharm Stat Journal subject: FARMACOLOGIA Year: 2021 Document type: Article Affiliation country: