April 4th 2025:
“Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map” has just been published in the Springer Nature online BMC Journal, Trials. The review, led by Dr David Keane was carried out by collaborators from CÚRAM, the HRB Clinical Research Facility and the HRB Trials Methodology Research network at University of Galway, the Saolta University Hospital Group, Galway, Cardiac Physiology group at Sherwood Forest Hospitals NHS Foundation Trust in Nottinghamshire, UK., University of Galway Library, University of Limerick Hospital Group, School of Chemical and Biopharmaceutical Sciences, Technological University Dublin, Health Economics and Policy Analysis Centre, University of Galway, and the Regenerative Medicine Institute (REMEDI), School of Medicine at University of Galway.
Dr Keane has a background in medical physics with 15 years in the NHS as a registered Clinical Scientist. His research and clinical work focused on the use and evaluation of technology to support people with kidney failure. David now works in CÚRAM, developing clinical trial methodology and infrastructure for medical devices under the supervision of Professor Matthew Griffin. Here he explains more about the work that led to the publication.
How did you identify the need for this review?
In CÚRAM, I work as part of the Translational Pillar, a team with very different academic interests who come together to try and ensure CÚRAM projects and their researchers are best equipped to bring their devices towards clinical use and patient benefit. Within the pillar, my interest is in clinical trial design. Unlike with novel pharmaceuticals, where the series of clinical trials needed to support bringing a drug to market is firmly established, medical devices come to market with varying amounts of clinical studies behind them. There are very few broad reviews looking across device types and clinical areas – partly for good reason, a finger splint has little in common with a ventilator providing life support. However, we felt that the regulatory environment, iterative nature of design and rapid innovation that tends to be common across devices supported the idea of taking a very broad view of the published clinical investigations of medical devices.
What is the most important finding of the review?
The scale of the review, which only really became apparent as we started to design our literature search, made it impossible to make absolute statements. But the data highlighted some really interesting findings. We took studies from periods in 2012 and 2022 to allow us to see changes over a decade. There was a 2.5-fold increase in the number of studies, a demonstrable increase in the quality of the studies and in the quality of the journals they were published in. Although across time periods, there were relatively few studies that demonstrated best practice in design and reporting. The actual study design – e.g. whether you set up a registry or plan a randomised controlled trial – should be guided by ethical and resource constraints – but there is no justification for studies to be published without information on ethical approvals or statistical justification of the study population, as we often found. We also noted an interesting shift in the proportion of studies conducted in Europe and USA towards Asia, which interested those in our group with a keen eye on regulatory aspects.
Who will benefit from this work and why?
Primarily, we hope this work will highlight the need for clinical trial expertise in device development projects. Clinical data is ultimately fundamental to regulatory approval, reimbursement and trust from clinical and patient communities. It can also be very expensive to generate clinical data which reinforces the need to develop optimal trial designs! We hope this will help more device developers to be able to provide the level of clinical evidence that is consistently sought by regulators and clinicians and support translation of the devices to patient benefit.
What did the different collaborators bring to the project?
This was maybe my favourite part of the project, as we developed a really diverse team! Within the Translational Pillar in CÚRAM, we really enjoy coming together to support CÚRAM device projects, but this project allowed me to work on original research with some of the team. The type of data generated from clinical investigations of medical devices underpins regulatory approvals and health economic analyses. Paddy Gillespie and Elaine Harris from our pillar ensured that the project was applied to these contexts, as well as to trial design, which is the focus of my work with Matt Griffin. Our centre director, Abhay Pandit brought his deep understanding of the global medical device landscape to the table. Rosie Dunne is an information specialist in our Library and she was absolutely crucial in transforming our hazy research question into a realistic search strategy. But the most important people in the project were brothers Danny and Thomas Mathew – two Non-Consultant Hospital Doctors – and a Clinical Engineer whose training I supervised in the NHS before I moved to Galway. Between us, we manually screened about 6500 abstracts (in duplicate) and extracted data from about 2500. I’m getting traumatic flashbacks just thinking about it…
What are the next steps for this research?
We think there is value in further evidence synthesis on this topic. We were awarded funding from the HRB Trials Methodology Research Network to fund an undergraduate summer scholar to specifically review the design of clinical investigations of medical devices in Ireland. Although addressing a similar question, the much-reduced scope allowed us to get more granular detail on the studies. We are finalising the manuscript for publication, which showed expected hubs of medical device activity in Galway and Dublin as well as less expected locations for investigations, such as Kildare! We are also thinking about reviewing the types of clinical studies of most relevance to CÚRAM researchers – first in human trials of biomaterials and implants – to see what we learnings we can bring into our project support work.
What would you like to see change in how medical devices are investigated?
One thing we didn’t review in our project was the extent of patient and public involvement (PPI) in the planning of clinical studies. And this was largely because it is so infrequently reported. However, we know this is changing and personally it is great to see CÚRAM’s commitment to embedding PPI in all its projects. I have seen first-hand the difference of having an empowered patient voice as part of a team designing a clinical study and not being brought in to tick a box after the study has largely been already designed. So early, meaningful PPI would be the change I’d most like to see. And if that happened, I wouldn’t be surprised if some of the other issues we highlight in this project were better managed!
The full article can be accessed at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08793-y
Ends.
