Flight, L. orcid.org/0000-0002-9569-8290 and Julious, S.A. (2016) Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharmaceutical Statistics, 15 (1). pp. 80-89. ISSN 1539-1604
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 John Wiley & Sons. This is an author produced version of a paper subsequently published in Pharmaceutical Statistics. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | sample size; non-inferiority; equivalence; power; clinical trials |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 06 Apr 2016 13:33 |
Last Modified: | 28 Nov 2016 10:28 |
Published Version: | http://dx.doi.org/10.1002/pst.1716 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/pst.1716 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:97113 |