Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map.

Abstract

Background Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects. Methods We developed a search for EMBASE that identified clinical investigations of medical devices during two discrete 3-month periods at the end of 2012 and of 2022. Core information from observational studies was extracted along with details on study design in interventional studies. We developed an evidence map of published studies across device type and clinical specialty and summarised study design aspects. Results We included 682 studies from 2012 and 1682 studies from 2022. Around a quarter of studies were interventional and the remainder being observational and primary outcomes of effectiveness were more common than efficacy. Key study design aspects were frequently unreported, including sample size justification, registration, randomisation technique and funders. Our evidence map demonstrated that predominantly, investigations were of implants and were in a cardiovascular setting. Clinical investigations were broadly similar between 2012 and 2022, though there was a reduction in the proportion of cardiovascular studies, a move in the share of studies coming out of Europe and North America towards Asia and a general improvement in the quality of study design reported. Conclusions Implanted devices in cardiovascular disease and orthopaedics are the focus of a large proportion of published clinical investigations of medical devices. Reporting of key study design aspects of clinical investigations of medical devices are improving but are still below expected requirements.