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

• Published in: Current controlled trials in cardiovascular medicine 2017-09, Vol.18 (1), p.427-427, Article 427
• Main Authors: Neugebauer, Edmund A M, Rath, Ana, Antoine, Sunya-Lee, Eikermann, Michaela, Seidel, Doerthe, Koenen, Carsten, Jacobs, Esther, Pieper, Dawid, Laville, Martine, Pitel, Séverine, Martinho, Cecilia, Djurisic, Snezana, Demotes-Mainard, Jacques, Kubiak, Christine, Bertele, Vittorio, Jakobsen, Janus C, Garattini, Silvio, Gluud, Christian
• Format: Article
• Language: English
• Subjects: Assessment; Clinical medicine; Clinical trials; Endpoint Determination; Equipment and Supplies - adverse effects; Evidence-based clinical practice; Evidence-based medicine; Humans; Life Sciences; Management; Marketing; Medical device industry; Medical devices; Medical equipment; Medical technology; Pacemakers; Patient safety; Physiological apparatus; Product development; Randomised clinical trials; Randomized Controlled Trials as Topic - methods; Rare diseases; Research Design; Review; Risk Assessment; Small & medium sized enterprises-SME; Specific barriers; Testing; Time Factors; Treatment Outcome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-017-2168-0

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. 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. 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. 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.