Julious, S.A. and Campbell, M.J. orcid.org/0000-0003-3529-2739 (2012) Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data. Statistics in Medicine , 31 (24). pp. 2904-2936. ISSN 0277-6715
Abstract
This article gives an overview of sample size calculations for a single response and a comparison of two responses in a parallel group trial where the outcome is binary. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non‐inferiority and estimation to a given precision. For each type of trial the null and alternative hypotheses are described and how the impact these have on the sample size calculations. For each type of trial the calculations are highlighted through worked examples. Sample size tables for the different types of trials and worked examples are given to assist in future calculations. Copyright © 2012 John Wiley & Sons, Ltd.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2012 John Wiley & Sons, Ltd. This is an author-produced version of a paper subsequently published in Statistics in Medicine. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | sample size; power; Type I error; Type II error; superiority trials; equivalence trials; non-inferiority trials; precision; single response; parallel group 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: | 29 Apr 2019 15:47 |
Last Modified: | 30 Apr 2019 01:40 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/sim.5381 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:145472 |