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- W1969934218 abstract "The traditional fixed margin approach to evaluating an experimental treatment through an active-controlled noninferiority trial is simple and straightforward. However, its utility relies heavily on the constancy assumption of the experimental data. The recently developed covariate-adjustment method permits more flexibility and improved discriminatory capacity compared to the fixed margin approach. However, one major limitation of this covariate-adjustment methodology is its adherence on the patient-level data, which may not be accessible to investigators in practice. In this article, under some assumptions, we examine the feasibility of a partial covariate-adjustment approach based on data typically available from journal publications or other public data when the patient-level data are unavailable. We illustrate the usefulness of this approach through two real examples. We also provide design considerations on the efficiency of the partial covariate-adjustment approach." @default.
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- W1969934218 date "2013-08-19" @default.
- W1969934218 modified "2023-09-26" @default.
- W1969934218 title "A Note on Partial Covariate-Adjustment and Design Considerations in Noninferiority Trials When Patient-Level Data are not Available" @default.
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- W1969934218 doi "https://doi.org/10.1080/10543406.2013.813523" @default.
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