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Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial
PURPOSE: The early identification of maximum tolerated dose (MTD) in phase I trial leads to faster progression to a phase II trial or an expansion cohort to confirm efficacy. METHODS: We propose a novel adaptive design for identifying MTD early to accelerate dose-finding trials. The early identifica...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8985324/ https://www.ncbi.nlm.nih.gov/pubmed/35382745 http://dx.doi.org/10.1186/s12874-022-01584-y |
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author | Kojima, Masahiro |
author_facet | Kojima, Masahiro |
author_sort | Kojima, Masahiro |
collection | PubMed |
description | PURPOSE: The early identification of maximum tolerated dose (MTD) in phase I trial leads to faster progression to a phase II trial or an expansion cohort to confirm efficacy. METHODS: We propose a novel adaptive design for identifying MTD early to accelerate dose-finding trials. The early identification of MTD is determined adaptively by dose-retainment probability using a trial data via Bayesian analysis. We applied the early identification design to an actual trial. A simulation study evaluates the performance of the early identification design. RESULTS: In the actual study, we confirmed the MTD could be early identified and the study period was shortened. In the simulation study, the percentage of the correct MTD selection in the early identification Keyboard and early identification Bayesian optimal interval (BOIN) designs was almost same from the non-early identification version. The early identification Keyboard and BOIN designs reduced the study duration by about 50% from the model-assisted designs. In addition, the early identification Keyboard and BOIN designs reduced the study duration by about 20% from time-to-event model-assisted designs. CONCLUSION: We proposed the early identification of MTD maintaining the accuracy to be able to short the study period. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-022-01584-y. |
format | Online Article Text |
id | pubmed-8985324 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-89853242022-04-07 Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial Kojima, Masahiro BMC Med Res Methodol Research PURPOSE: The early identification of maximum tolerated dose (MTD) in phase I trial leads to faster progression to a phase II trial or an expansion cohort to confirm efficacy. METHODS: We propose a novel adaptive design for identifying MTD early to accelerate dose-finding trials. The early identification of MTD is determined adaptively by dose-retainment probability using a trial data via Bayesian analysis. We applied the early identification design to an actual trial. A simulation study evaluates the performance of the early identification design. RESULTS: In the actual study, we confirmed the MTD could be early identified and the study period was shortened. In the simulation study, the percentage of the correct MTD selection in the early identification Keyboard and early identification Bayesian optimal interval (BOIN) designs was almost same from the non-early identification version. The early identification Keyboard and BOIN designs reduced the study duration by about 50% from the model-assisted designs. In addition, the early identification Keyboard and BOIN designs reduced the study duration by about 20% from time-to-event model-assisted designs. CONCLUSION: We proposed the early identification of MTD maintaining the accuracy to be able to short the study period. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-022-01584-y. BioMed Central 2022-04-06 /pmc/articles/PMC8985324/ /pubmed/35382745 http://dx.doi.org/10.1186/s12874-022-01584-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/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/ (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 | Research Kojima, Masahiro Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title | Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title_full | Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title_fullStr | Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title_full_unstemmed | Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title_short | Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
title_sort | adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8985324/ https://www.ncbi.nlm.nih.gov/pubmed/35382745 http://dx.doi.org/10.1186/s12874-022-01584-y |
work_keys_str_mv | AT kojimamasahiro adaptivedesignforidentifyingmaximumtolerateddoseearlytoacceleratedosefindingtrial |