Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project
Alan G. Fraser (Katholieke Universiteit Leuven, University Hospital of Wales)
Sergio Buccheri (Uppsala Clinical Research Center)
Robert A. Byrne (Mater Private Network, RCSI University)
Per Kjaersgaard-Andersen (South Danish University)
Stefan James (Uppsala Clinical Research Center)
Peter Jüni (Clinical Trial Service Unit and Epidemiological Studies Unit)
Lia Bally (University Hospital of Psychiatry)
Richard Bulbulia (Clinical Trial Service Unit and Epidemiological Studies Unit)
Berthold V. Koletzko (Klinikum der Universität München)
Martin J. Landray (Clinical Trial Service Unit and Epidemiological Studies Unit)
Claudia Louati (European Patients Forum)
Anne Lübbeke (University of Oxford, University Hospital of Geneva)
Perla J. Marang-van de Mheen (TU Delft - Technology, Policy and Management)
Peter McCulloch (University of Oxford)
Bernadeta Patro-Golab (Klinikum der Universität München)
Petra Schnell-Inderst (UMIT Tirol)
Frank E. Rademakers (Katholieke Universiteit Leuven)
George C.M. Siontis (University Hospital of Psychiatry)
Marina Torre (Viale Regina Elena)
Claudia Wild (Austrian Institute of Health Technology Assessment)
Yasemin Zeisl (European Patients Forum)
Tom Melvin (National University of Ireland Galway)
Rob G.H.H. Nelissen (Leiden University Medical Center)
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Abstract
Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so the European Commission funded the CORE–MD project (Coordinating Research and Evidence for Medical Devices) to advise regulators on appropriate designs for clinical trials of high-risk devices. The CORE–MD consortium recommends that evaluation should be planned in four stages. Randomised controlled trials should be performed more often, against active comparators reflecting the best available treatment, or using sham interventions with ethical safeguards. Large trials can be managed efficiently using an electronic database or registry. Non-randomised clinical studies can apply objective performance criteria or other validated patient-relevant outcome measures, with adjustments to minimise bias. Full transparency of results from clinical investigations is essential. Proportionate regulation of breakthrough or orphan devices for independently-defined serious unmet needs may involve approval with less evidence, but on condition of subsequent confirmatory studies. These CORE–MD consensus proposals have been submitted to European Union medical device regulators, to be considered as a basis for more transparent and predictable requirements for clinical evidence. Funding: The CORE–MD project was funded as a Coordination and Support action from the European Union Horizon 2020 research and innovation programme, under grant agreement 965246.
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