Unreported medical device trials in the UK: Mission not (yet) accomplished
In recent years, numerous universities and NHS Trusts across the UK have significantly improved their reporting of the results of drug trials.
However, it appears that at many leading institutions, these laudable efforts have not been extended to trials of medical devices, which often are of equal or even greater importance to patients.
In early April, TranspariMED filed Freedom of Information (FOI) requests with the 15 universities and 5 NHS Trusts in the country with the largest number of non-drug trials in their portfolios.
Institutions were asked to provide a list of all non-drug trials completed or terminated during the years 2006-2015, together with their registry ID numbers, completion dates, participant numbers and hyperlinks to where the trials’ results had been reported.
Out of the 20 institutions contacted:
4 provided relevant data
4 have still not replied to the FOI request
12 refused the request
Institutions refusing to provide the data argued that they do not hold this information centrally, and that gathering it would involve a workload exceeding the limits set out by FOI legislation.
University and NHS Trust portfolios probably contain a significant number of non-drug trials that have never made their results public, and are thus in acute danger of becoming research waste. Experience shows that in institutions that lack central oversight, clinical trial results are regularly reported late or not at all. The FOI responses suggest that a majority of institutions do not have central oversight over the non-drug trials that they completed during 2006-2015.
In the wake of a 2018-2019 parliamentary enquiry, many UK institutions overhauled their policies and processes. In some cases, they did include non-drug trials in the scope of their efforts, but typically only for future trials. This means that while some institutions now have central oversight of their recent non-drug trials, only few have oversight of such trials that were completed many years ago.
Previous research by TranspariMED suggests that NHS Trusts alone have left the results of around 500 clinical trials unreported, putting medical research worth over £250 million at risk of becoming research waste.
Why are trials of medical devices being neglected?
The 2018-2019 parliamentary enquiry focused almost exclusively on drug trials because data on institutions’ regulatory compliance was readily available through the EU Trials Tracker. Comparable data on their reporting of non-drug trials did not exist because gathering it would have required time-intensive manual searches. Hence, while there was significant political and public pressure on universities and NHS Trusts to get on top of drug trial reporting, including for trials completed many years ago, their other trials continued to fly under the radar.
While there is a clear ethical and scientific obligation to make public the results of all interventional clinical trials, trials of drugs (so-called CTIMPs) are regulated differently from non-drug trials in the UK and across the European Union. Drug trials must be registered on the European trial registry, and the institutions running them are obliged to later upload their results onto that same registry. In contrast, trials of medical devices and other non-drug interventions may be registered on a variety of other WHO primary registries, and there is no regulatory obligation to make their results public.
Over the coming months, TranspariMED will continue its efforts to identify medical device trials left unreported by UK universities and NHS Trusts.
TranspariMED will then give 20 universities and NHS Trusts lists of their completely unreported non-drug trials so that these institutions can take action before their medical research results get lost forever.
This work is part of a project funded by HealthWatch, a UK charity that promotes science and integrity in healthcare.