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Systematic review of available software for multi-arm multi-stage and platform clinical trial design

BACKGROUND: In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial de...

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Autores principales: Meyer, Elias Laurin, Mesenbrink, Peter, Mielke, Tobias, Parke, Tom, Evans, Daniel, König, Franz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931508/
https://www.ncbi.nlm.nih.gov/pubmed/33663579
http://dx.doi.org/10.1186/s13063-021-05130-x
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author Meyer, Elias Laurin
Mesenbrink, Peter
Mielke, Tobias
Parke, Tom
Evans, Daniel
König, Franz
author_facet Meyer, Elias Laurin
Mesenbrink, Peter
Mielke, Tobias
Parke, Tom
Evans, Daniel
König, Franz
author_sort Meyer, Elias Laurin
collection PubMed
description BACKGROUND: In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial design remain and are often further complicated by the complexity of such trial designs. METHODS: A systematic search was conducted to review existing software for the design of platform trials, whereby multi-arm multi-stage trials were also included. The results of this search are reported both on the literature level and the software level, highlighting the software judged to be particularly useful. RESULTS: In recent years, many highly specialized software packages targeting single design elements on platform studies have been released. Only a few of the developed software packages provide extensive design flexibility, at the cost of limited access due to being commercial or not being usable as out-of-the-box solutions. CONCLUSIONS: We believe that both an open-source modular software similar to OCTOPUS and a collaborative effort will be necessary to create software that takes advantage of and investigates the impact of all the flexibility that platform trials potentially provide. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05130-x.
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spelling pubmed-79315082021-03-05 Systematic review of available software for multi-arm multi-stage and platform clinical trial design Meyer, Elias Laurin Mesenbrink, Peter Mielke, Tobias Parke, Tom Evans, Daniel König, Franz Trials Review BACKGROUND: In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial design remain and are often further complicated by the complexity of such trial designs. METHODS: A systematic search was conducted to review existing software for the design of platform trials, whereby multi-arm multi-stage trials were also included. The results of this search are reported both on the literature level and the software level, highlighting the software judged to be particularly useful. RESULTS: In recent years, many highly specialized software packages targeting single design elements on platform studies have been released. Only a few of the developed software packages provide extensive design flexibility, at the cost of limited access due to being commercial or not being usable as out-of-the-box solutions. CONCLUSIONS: We believe that both an open-source modular software similar to OCTOPUS and a collaborative effort will be necessary to create software that takes advantage of and investigates the impact of all the flexibility that platform trials potentially provide. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05130-x. BioMed Central 2021-03-04 /pmc/articles/PMC7931508/ /pubmed/33663579 http://dx.doi.org/10.1186/s13063-021-05130-x Text en © The Author(s) 2021 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://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 Review
Meyer, Elias Laurin
Mesenbrink, Peter
Mielke, Tobias
Parke, Tom
Evans, Daniel
König, Franz
Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title_full Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title_fullStr Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title_full_unstemmed Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title_short Systematic review of available software for multi-arm multi-stage and platform clinical trial design
title_sort systematic review of available software for multi-arm multi-stage and platform clinical trial design
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931508/
https://www.ncbi.nlm.nih.gov/pubmed/33663579
http://dx.doi.org/10.1186/s13063-021-05130-x
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