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

Abstract : BackgroundMedical 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.MethodsSystematic 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.ResultsIn 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.ConclusionsThe 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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Trials, BioMed Central, 2016, 18 (1), pp.427. 〈10.1186/s13063-017-2168-0〉
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Edmund Neugebauer, Ana Rath, Sunya-Lee Antoine, Michaela Eikermann, Doerthe Seidel, et al.. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials, BioMed Central, 2016, 18 (1), pp.427. 〈10.1186/s13063-017-2168-0〉. 〈inserm-01588783〉

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