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Specific barriers to the conduct of randomised clinical trials on medical devices

Publikation: Forskning - peer reviewTidsskriftartikel

DOI

  • Edmund A M Neugebauer
  • Ana Rath
  • Sunya-Lee Antoine
  • Michaela Eikermann
  • Doerthe Seidel
  • Carsten Koenen
  • Esther Jacobs
  • Dawid Pieper
  • Martine Laville
  • Séverine Pitel
  • Cecilia Martinho
  • Snezana Djurisic
  • Jacques Demotes-Mainard
  • Christine Kubiak
  • Vittorio Bertele'
  • Janus C Jakobsen
  • Silvio Garattini
  • Christian Gluud
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BACKGROUND: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices.

METHODS: Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.

RESULTS: In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency.

CONCLUSIONS: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.

OriginalsprogEngelsk
TidsskriftTrials
Vol/bind18
Tidsskriftsnummer1
Sider (fra-til)427
ISSN1745-6215
DOI
StatusUdgivet - 13 sep. 2017

ID: 51687644