Section 59
Chapter 58,589

Practical guide to sample size calculations: non-inferiority and equivalence trials

Flight, L.; Julious, S.A.

Pharmaceutical Statistics 15(1): 80-89


ISSN/ISBN: 1539-1612
PMID: 26604186
DOI: 10.1002/pst.1716
Accession: 058588176

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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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