Table 1 Perceived or actual barriers to the conduct of randomised clinical trials (RCTs) within medical devices (MDs), and potential solutions

Timing of the assessment

Extensive preclinical testing is necessary before application to the first patient. Short timelines necessary. The Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) collaboration developed a framework for different study types for the different stages of surgical innovation, which is also supported by the members of the methodological expert panel. By any means, an assessment should take place before an MD is widely distributed.

Acceptability

One possibility is an expertise-based randomised clinical trial. The advantages are better acceptability and reduction of execution bias and protocol deviations.

Blinding in MD trials difficult

Blinding may be complete, partial or only apply to the assessment of endpoints. Blinding of outcome assessors should be possible in most studies and should be used as a standard procedure whenever possible – objective endpoints should be preferably adopted.

Comparator in MD trials

Treatment in comparator arms should be selected per existing standards of medical care and best-available evidence on existing treatments. The possibility that more than one comparator is appropriate or different comparators exist in specific subgroups should be considered.

Learning curve

The learning phase must be considered in the trial so that any benefit provided by the device or health technology can be evaluated accurately. Trainee’s prior experience should be quantified, the case mix and complexity should ideally be constant and the level of supervision received should be fully described.

Minimal requirements for outcome assessment

A common understanding on the concept of outcomes is missing in the MD industry. The outcomes included in the analysis should reflect the whole procedure and all different kinds of settings the MD can be used in. For MDs, the MD outcome measure database was developed by the European Clinical Research Infrastructure Network (ECRIN) and is now online. For long-term outcomes, RCTs should be supplemented by parallel prospective registry data. Registry-based RCTs should be considered.

Transparency

In the current Regulation, the study protocol and a summary of the results are to be made publicly available in European databases for clinical trials.

Early scientific advice and expert panels

Early scientific advice with regard to the clinical development strategy and clinical studies for their devices is proposed.

Information about clinical trial regulatory and ethical requirements

Country-specific information on regulatory and ethical requirements in MD studies are available.