title: Practical guide to sample size calculations: non-inferiority and equivalence trials.
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.
authors.affiliation: Medical Statistics Group, The University of Sheffield, Sheffield, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Flight
authors.affiliation: Medical Statistics Group, The University of Sheffield, Sheffield, UK.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Julious
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D018401:Sample Size; D013810:Therapeutic Equivalency
keywords: clinical trials; equivalence; non-inferiority; power; sample size