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Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?

Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-r...

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Autores principales: Sharma, Ricky A, Fumi, Lucio, Audisio, Riccardo A, Denys, Alban, Wood, Bradford J, Pignatti, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The British Institute of Radiology. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965466/
https://www.ncbi.nlm.nih.gov/pubmed/29172678
http://dx.doi.org/10.1259/bjr.20170643
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author Sharma, Ricky A
Fumi, Lucio
Audisio, Riccardo A
Denys, Alban
Wood, Bradford J
Pignatti, Francesco
author_facet Sharma, Ricky A
Fumi, Lucio
Audisio, Riccardo A
Denys, Alban
Wood, Bradford J
Pignatti, Francesco
author_sort Sharma, Ricky A
collection PubMed
description Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. In this article, we argue that, to generate convincing evidence of clinical efficacy and safety, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial. We also propose that, when a comprehensive clinical data package is not feasible, limited clinical data can be supplemented with other types of evidence. Emerging life science companies often define the “valley of death” after securing initial investment to translate an early medical device concept to a development stage that is attractive to funders. Unfortunately for this industry, there is a second “valley of death” if the focus and goal is only regulatory approval, to the neglect of clinical acceptance and reimbursement. For the emerging specialism of interventional oncology, it is critical to plan a clear line of sight for each new medical device to avoid the valleys of death and to demonstrate the clinical benefit. Increased international guidance to establish realistic yet convincing standards in this area may avoid attrition of potentially beneficial devices and therapeutic procedures in the valleys of death.
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spelling pubmed-59654662019-03-01 Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices? Sharma, Ricky A Fumi, Lucio Audisio, Riccardo A Denys, Alban Wood, Bradford J Pignatti, Francesco Br J Radiol Commentary Whereas clinical trials of cancer drugs have methodological standards and conventional primary endpoints, these are not necessarily applicable to the clinical development of loco-regional treatments and new medical devices. The current challenge is to generate high-level clinical evidence for loco-regional treatments to define the benefits for patients. In this article, we argue that, to generate convincing evidence of clinical efficacy and safety, the collective coherence of the entire data package is often more important than the primary endpoint of one clinical trial. We also propose that, when a comprehensive clinical data package is not feasible, limited clinical data can be supplemented with other types of evidence. Emerging life science companies often define the “valley of death” after securing initial investment to translate an early medical device concept to a development stage that is attractive to funders. Unfortunately for this industry, there is a second “valley of death” if the focus and goal is only regulatory approval, to the neglect of clinical acceptance and reimbursement. For the emerging specialism of interventional oncology, it is critical to plan a clear line of sight for each new medical device to avoid the valleys of death and to demonstrate the clinical benefit. Increased international guidance to establish realistic yet convincing standards in this area may avoid attrition of potentially beneficial devices and therapeutic procedures in the valleys of death. The British Institute of Radiology. 2018-03 2018-01-19 /pmc/articles/PMC5965466/ /pubmed/29172678 http://dx.doi.org/10.1259/bjr.20170643 Text en © 2018 The Authors. Published by the British Institute of Radiology http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 Unported License http://creativecommons.org/licenses/by/4.0/, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
spellingShingle Commentary
Sharma, Ricky A
Fumi, Lucio
Audisio, Riccardo A
Denys, Alban
Wood, Bradford J
Pignatti, Francesco
Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title_full Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title_fullStr Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title_full_unstemmed Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title_short Commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
title_sort commentary: how will interventional oncology navigate the “valleys of death” for new medical devices?
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965466/
https://www.ncbi.nlm.nih.gov/pubmed/29172678
http://dx.doi.org/10.1259/bjr.20170643
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