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
UR - http://www.scopus.com/inward/record.url?scp=85029407256&partnerID=8YFLogxK
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 -