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Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology
In this commentary, using existing clinical trial data and FDA approvals we propose that there is currently a critical need for an appropriate balancing between the financial impact of new cancer drugs and their actual benefit for patients. By adopting “pleural mesothelioma” as our clinical model we...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9749371/ https://www.ncbi.nlm.nih.gov/pubmed/36514092 http://dx.doi.org/10.1186/s12967-022-03744-6 |
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author | Meirson, Tomer Nardone, Valerio Pentimalli, Francesca Markel, Gal Bomze, David D’Apolito, Maria Correale, Pierpaolo Giordano, Antonio Pirtoli, Luigi Porta, Camillo Gray, Steven G Mutti, Luciano |
author_facet | Meirson, Tomer Nardone, Valerio Pentimalli, Francesca Markel, Gal Bomze, David D’Apolito, Maria Correale, Pierpaolo Giordano, Antonio Pirtoli, Luigi Porta, Camillo Gray, Steven G Mutti, Luciano |
author_sort | Meirson, Tomer |
collection | PubMed |
description | In this commentary, using existing clinical trial data and FDA approvals we propose that there is currently a critical need for an appropriate balancing between the financial impact of new cancer drugs and their actual benefit for patients. By adopting “pleural mesothelioma” as our clinical model we summarize the most relevant pertinent and available literature on this topic, and use an analysis of the reliability of the trials submitted for registration and/or recently published as a case in point to raise concerns with respect to appropriate trial design, biomarker based stratification and to highlight the ongoing need for balancing the benefit/cost ratio for both patients and healthcare providers. |
format | Online Article Text |
id | pubmed-9749371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-97493712022-12-15 Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology Meirson, Tomer Nardone, Valerio Pentimalli, Francesca Markel, Gal Bomze, David D’Apolito, Maria Correale, Pierpaolo Giordano, Antonio Pirtoli, Luigi Porta, Camillo Gray, Steven G Mutti, Luciano J Transl Med Commentary In this commentary, using existing clinical trial data and FDA approvals we propose that there is currently a critical need for an appropriate balancing between the financial impact of new cancer drugs and their actual benefit for patients. By adopting “pleural mesothelioma” as our clinical model we summarize the most relevant pertinent and available literature on this topic, and use an analysis of the reliability of the trials submitted for registration and/or recently published as a case in point to raise concerns with respect to appropriate trial design, biomarker based stratification and to highlight the ongoing need for balancing the benefit/cost ratio for both patients and healthcare providers. BioMed Central 2022-12-13 /pmc/articles/PMC9749371/ /pubmed/36514092 http://dx.doi.org/10.1186/s12967-022-03744-6 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 | Commentary Meirson, Tomer Nardone, Valerio Pentimalli, Francesca Markel, Gal Bomze, David D’Apolito, Maria Correale, Pierpaolo Giordano, Antonio Pirtoli, Luigi Porta, Camillo Gray, Steven G Mutti, Luciano Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title | Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title_full | Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title_fullStr | Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title_full_unstemmed | Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title_short | Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
title_sort | analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9749371/ https://www.ncbi.nlm.nih.gov/pubmed/36514092 http://dx.doi.org/10.1186/s12967-022-03744-6 |
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