Titre
Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?
Type
synthèse (review)
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Sharma, R.A.
Auteure/Auteur
Fumi, L.
Auteure/Auteur
Audisio, R.A.
Auteure/Auteur
Denys, A.
Auteure/Auteur
Wood, B.J.
Auteure/Auteur
Pignatti, F.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1748-880X
Statut éditorial
Publié
Date de publication
2018-02
Volume
91
Numéro
1083
Première page
20170643
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Résumé
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.
PID Serval
serval:BIB_85E7347B93D2
PMID
Date de création
2018-03-02T10:36:08.535Z
Date de création dans IRIS
2025-05-21T03:47:02Z
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Nom
29172678_BIB_85E7347B93D2.pdf
Version du manuscrit
published
Taille
140.37 KB
Format
Adobe PDF
PID Serval
serval:BIB_85E7347B93D2.P001
URN
urn:nbn:ch:serval-BIB_85E7347B93D20
Somme de contrôle
(MD5):79d15d58d06eda44b46aa0cdcbc4509e