Practical guide to sample size calculations: non‐inferiority and equivalence trials |
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| Authors: | Laura Flight Steven A Julious |
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| Institution: | Medical Statistics Group, The University of Sheffield, Sheffield, UK |
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| Abstract: | A sample size justification is a vital part of any trial design. However, estimating the number of participants required to give a meaningful result is not always straightforward. A number of components are required to facilitate a suitable sample size calculation. In this paper, the steps for conducting sample size calculations for non‐inferiority and equivalence trials are summarised. Practical advice and examples are provided that illustrate how to carry out the calculations by hand and using the app SampSize. Copyright © 2015 John Wiley & Sons, Ltd. |
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| Keywords: | sample size non‐inferiority equivalence power clinical trials |
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