doi: 10.1002/pst.1716.
Epub 2015 Nov 25.
Practical guide to sample size calculations: non-inferiority and equivalence trials
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- PMID: 26604186
- DOI: 10.1002/pst.1716
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Practical guide to sample size calculations: non-inferiority and equivalence trials
Pharm Stat.
2016 Jan-Feb.
Free article
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.
Keywords: clinical trials; equivalence; non-inferiority; power; sample size.
Copyright © 2015 John Wiley & Sons, Ltd.
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