Julious, S.A. (2004) Tutorial in biostatistics - Sample sizes for clinical trials with Normal data. Statistics in Medicine, 23 (12). pp. 1921-1986. ISSN 0277-6715
Abstract
This article gives an overview of sample size calculations for parallel group and cross‐over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non‐inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2004 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; bioequivalence; precision; baselines; cross-over trials; 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 15:59 |
Last Modified: | 29 Apr 2019 15:59 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/sim.1783 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:145474 |