Cargando…
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...
Autores principales: | , , , , , |
---|---|
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 |
_version_ | 1783660308789723136 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7931508 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT meyereliaslaurin systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT mesenbrinkpeter systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT mielketobias systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT parketom systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT evansdaniel systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT konigfranz systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign AT systematicreviewofavailablesoftwareformultiarmmultistageandplatformclinicaltrialdesign |