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Published in: Trials 1/2017

Open Access 01-12-2017 | Review

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

Authors: 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

Published in: Trials | Issue 1/2017

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Abstract

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.
Appendix
Available only for authorised users
Footnotes
1
Funded by the European Union Framework Programme 7 (EU FP7; grant agreement no. 284395), ECRIN-IA involved 23 countries and brought together diverse stakeholders to overcome barriers to clinical research in three particularly difficult areas (rare diseases, medical devices and nutrition). Specifically, the project aimed to develop tools, services and infrastructure to facilitate multinational clinical research in Europe, and to support the development of pan-European disease networks to drive clinical projects. This, in turn, was intended to improve Europe’s attractiveness to industry, boost its scientific competitiveness and result in better healthcare for European citizens. Originally planned for 4 years (2012 to 2015), the clinical trials work package was extended until 2017.
 
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Metadata
Title
Specific barriers to the conduct of randomised clinical trials on medical devices
Authors
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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2168-0

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