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

Laura Flight; Steven A Julious

doi:10.1002/pst.1716

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

Pharm Stat. 2016 Jan-Feb;15(1):80-9. doi: 10.1002/pst.1716. Epub 2015 Nov 25.

Authors

Laura Flight¹, Steven A Julious¹

Affiliation

¹ Medical Statistics Group, The University of Sheffield, Sheffield, UK.

PMID: 26604186
DOI: 10.1002/pst.1716

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic / methods
Clinical Trials as Topic / statistics & numerical data*
Humans
Sample Size*
Therapeutic Equivalency*