Practical guide to sample size calculations: non‐inferiority and equivalence trials. (25th November 2015)

• Record Type: Journal Article
• Authors: Flight, Laura; Julious, Steven A.
• Is Part Of: Pharmaceutical statistics. Volume 15:Number 1(2016)
• Page Start: 80
• Page End: 89
• Publication Date: 2015-11-25
• Subjects: sample size -- non‐inferiority -- equivalence -- power -- clinical trials; Pharmacy -- Statistical methods -- Periodicals; Pharmacy -- Statistics -- Periodicals; 615.10727
• DOI: 10.1002/pst.1716
• Languages: English
• ISSNs: 1539-1604

Abstract

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.