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

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Serval ID
serval:BIB_85E7347B93D2
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?
Journal
The British journal of radiology
Author(s)
Sharma R.A., Fumi L., Audisio R.A., Denys A., Wood B.J., Pignatti F.
ISSN
1748-880X (Electronic)
ISSN-L
0007-1285
Publication state
Published
Issued date
02/2018
Peer-reviewed
Oui
Volume
91
Number
1083
Pages
20170643
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.

Keywords
Clinical Trials as Topic, Device Approval, Equipment Safety, Equipment and Supplies/economics, Humans, Investments, Medical Oncology, Neoplasms/therapy, Patient Safety, United States
Pubmed
Web of science
Create date
02/03/2018 11:36
Last modification date
20/08/2019 14:45
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