The importance of clinical importance when determining the target difference in sample size calculations

Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importan...

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Detalles Bibliográficos
Autores principales: Parker, Richard A., Cook, Jonathan A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401796/
https://www.ncbi.nlm.nih.gov/pubmed/37542276
http://dx.doi.org/10.1186/s13063-023-07532-5
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Cook, Jonathan A.
author_facet Parker, Richard A.
Cook, Jonathan A.
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description Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importance of a target difference is necessary in the context of randomised controlled trials of effectiveness, particularly definitive phase III trials. Ignoring clinical importance could have serious ethical and practical consequences.
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spelling pubmed-104017962023-08-05 The importance of clinical importance when determining the target difference in sample size calculations Parker, Richard A. Cook, Jonathan A. Trials Commentary Recently, it was argued that clinically important differences should play no role in sample size calculations. Instead, it was proposed that sample size calculations should focus on setting realistic estimates of treatment benefit. We disagree, and argue in this article that considering the importance of a target difference is necessary in the context of randomised controlled trials of effectiveness, particularly definitive phase III trials. Ignoring clinical importance could have serious ethical and practical consequences. BioMed Central 2023-08-04 /pmc/articles/PMC10401796/ /pubmed/37542276 http://dx.doi.org/10.1186/s13063-023-07532-5 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Parker, Richard A.
Cook, Jonathan A.
The importance of clinical importance when determining the target difference in sample size calculations
title The importance of clinical importance when determining the target difference in sample size calculations
title_full The importance of clinical importance when determining the target difference in sample size calculations
title_fullStr The importance of clinical importance when determining the target difference in sample size calculations
title_full_unstemmed The importance of clinical importance when determining the target difference in sample size calculations
title_short The importance of clinical importance when determining the target difference in sample size calculations
title_sort importance of clinical importance when determining the target difference in sample size calculations
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401796/
https://www.ncbi.nlm.nih.gov/pubmed/37542276
http://dx.doi.org/10.1186/s13063-023-07532-5
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