Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map

David F. Keane; Cherian Mathew; Ryan Longley; Rosie Dunne; Thomas Mathew; Elaine Harris; Paddy Gillespie; Abhay Pandit; Matthew D. Griffin

Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map

David F. Keane, Cherian Mathew, Ryan Longley, Rosie Dunne, Thomas Mathew, Elaine Harris, Paddy Gillespie, Abhay Pandit, Matthew D. Griffin

School of Chemical and BioPharmaceutical Science

Research output: Contribution to journal › Review article › peer-review

Abstract

Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects.

Original language	English
Article number	113
Journal	Trials
Volume	26
Issue number	1
Publication status	Published - 29 Mar 2025

Keywords

Clinical trial
Evidence map
Medical device
Scoping review

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Keane_et_al-2025-TrialsFinal published version, 1.69 MBLicence: CC BY

Cite this

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title = "Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map",

abstract = "Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects. ",

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AU - Keane, David F.

AU - Mathew, Cherian

AU - Longley, Ryan

AU - Dunne, Rosie

AU - Mathew, Thomas

AU - Harris, Elaine

AU - Gillespie, Paddy

AU - Pandit, Abhay

AU - Griffin, Matthew D.

PY - 2025/3/29

Y1 - 2025/3/29

N2 - Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects.

AB - Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects.

KW - Clinical trial

KW - Evidence map

KW - Medical device

KW - Scoping review

UR - https://www.scopus.com/pages/publications/105001498878

M3 - Review article

SN - 1745-6215

VL - 26

JO - Trials

JF - Trials

IS - 1

M1 - 113

ER -

Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map

Abstract

Keywords

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