Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology

Abstract 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...

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Main Authors: Tomer Meirson, Valerio Nardone, Francesca Pentimalli, Gal Markel, David Bomze, Maria D’Apolito, Pierpaolo Correale, Antonio Giordano, Luigi Pirtoli, Camillo Porta, Steven G Gray, Luciano Mutti
Format: Article
Language:English
Published: BMC 2022-12-01
Series:Journal of Translational Medicine
Online Access:https://doi.org/10.1186/s12967-022-03744-6
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author Tomer Meirson
Valerio Nardone
Francesca Pentimalli
Gal Markel
David Bomze
Maria D’Apolito
Pierpaolo Correale
Antonio Giordano
Luigi Pirtoli
Camillo Porta
Steven G Gray
Luciano Mutti
author_facet Tomer Meirson
Valerio Nardone
Francesca Pentimalli
Gal Markel
David Bomze
Maria D’Apolito
Pierpaolo Correale
Antonio Giordano
Luigi Pirtoli
Camillo Porta
Steven G Gray
Luciano Mutti
author_sort Tomer Meirson
collection DOAJ
description Abstract 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.
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spelling doaj.art-31b55a1ccc204e26bbba66e8945e4d5e2022-12-22T03:53:27ZengBMCJournal of Translational Medicine1479-58762022-12-012011910.1186/s12967-022-03744-6Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncologyTomer Meirson0Valerio Nardone1Francesca Pentimalli2Gal Markel3David Bomze4Maria D’Apolito5Pierpaolo Correale6Antonio Giordano7Luigi Pirtoli8Camillo Porta9Steven G Gray10Luciano Mutti11Davidoff Cancer Center, Rabin Medical Center-Beilinson HospitalDepartment of Precision Oncology, University Hospital of Campania L. VanvitelliDipartimento di Medicina e Chirurgia, Libera Università Mediterranea “Giuseppe Degennaro”Davidoff Cancer Center, Rabin Medical Center-Beilinson HospitalSackler Faculty of Medicine, Tel Aviv UniversityUnit of Medical Oncology, Oncology Department, Grand Metropolitan Hospital Bianchi Melacrino MorelliUnit of Medical Oncology, Oncology Department, Grand Metropolitan Hospital Bianchi Melacrino MorelliSbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple UniversitySbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple UniversityInterdisciplinary Department of Medicine, University of Bari “Aldo Moro” and A.O.U. Consorziale Policlinico di BariThoracic Oncology Research Group, Trinity St James’s Cancer Institute, St James’s HospitalSbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple UniversityAbstract 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.https://doi.org/10.1186/s12967-022-03744-6
spellingShingle Tomer Meirson
Valerio Nardone
Francesca Pentimalli
Gal Markel
David Bomze
Maria D’Apolito
Pierpaolo Correale
Antonio Giordano
Luigi Pirtoli
Camillo Porta
Steven G Gray
Luciano Mutti
Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology
Journal of Translational Medicine
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
url https://doi.org/10.1186/s12967-022-03744-6
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