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

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

doi:10.1186/s13063-017-2168-0

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

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

^*Corresponding author for this work

Medicine (HOL)

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

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.

Original language	English
Article number	427
Journal	Trials
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s13063-017-2168-0
Publication status	Published - 13 Sept 2017

Funding

1Funded 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.

Keywords

Assessment
European Clinical Research Infrastructure Network
Evidence-based clinical practice
Evidence-based medicine
Medical devices
Randomised clinical trials
Specific barriers

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10.1186/s13063-017-2168-0

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Neugebauer, E. A. M., Rath, A., Antoine, S. L., Eikermann, M., Seidel, D., Koenen, C., Jacobs, E., Pieper, D., Laville, M., Pitel, S., Martinho, C., Djurisic, S., Demotes-Mainard, J., Kubiak, C., Bertele, V., Jakobsen, J. C., Garattini, S., & Gluud, C. (2017). Specific barriers to the conduct of randomised clinical trials on medical devices. Trials, 18(1), Article 427. https://doi.org/10.1186/s13063-017-2168-0

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title = "Specific barriers to the conduct of randomised clinical trials on medical devices",

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.",

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Neugebauer, EAM, Rath, A, Antoine, SL, Eikermann, M, Seidel, D, Koenen, C, Jacobs, E, Pieper, D, Laville, M, Pitel, S, Martinho, C, Djurisic, S, Demotes-Mainard, J, Kubiak, C, Bertele, V, Jakobsen, JC, Garattini, S & Gluud, C 2017, 'Specific barriers to the conduct of randomised clinical trials on medical devices', Trials, vol. 18, no. 1, 427. https://doi.org/10.1186/s13063-017-2168-0

TY - JOUR

T1 - Specific barriers to the conduct of randomised clinical trials on medical devices

AU - Neugebauer, Edmund A.M.

AU - Rath, Ana

AU - Antoine, Sunya Lee

AU - Eikermann, Michaela

AU - Seidel, Doerthe

AU - Koenen, Carsten

AU - Jacobs, Esther

AU - Pieper, Dawid

AU - Laville, Martine

AU - Pitel, Séverine

AU - Martinho, Cecilia

AU - Djurisic, Snezana

AU - Demotes-Mainard, Jacques

AU - Kubiak, Christine

AU - Bertele, Vittorio

AU - Jakobsen, Janus C.

AU - Garattini, Silvio

AU - Gluud, Christian

PY - 2017/9/13

Y1 - 2017/9/13

N2 - 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.

AB - 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.

KW - Assessment

KW - European Clinical Research Infrastructure Network

KW - Evidence-based clinical practice

KW - Evidence-based medicine

KW - Medical devices

KW - Randomised clinical trials

KW - Specific barriers

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U2 - 10.1186/s13063-017-2168-0

DO - 10.1186/s13063-017-2168-0

M3 - Review

C2 - 28903769

AN - SCOPUS:85029407256

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

IS - 1

M1 - 427

ER -

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

Abstract

Funding

Keywords

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