Practical guide to sample size calculations: non‐inferiority and equivalence trials
Pharmaceutical Statistics2015Vol. 15(1), pp. 80–89
Citations Over TimeTop 10% of 2015 papers
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.
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