New European medical device database may undermine clinical trial transparency

Many results of clinical trials of medical device trials may remain unreported unless the European Commission takes corrective action soon, a new policy brief by Health Action International and TranspariMED warns.


NEW TRANSPARENCY RULES NEED SUPPORT


In May 2022, the new Eudamed database will go live. Its scope, scale and complexity are staggering. Eudamed will pull together a wealth of data on medical devices, including data on medical device trials. Numerous players, including manufacturers themselves, will enter data into the system.


The key question is whether thousands of manufacturers, which include many small and medium enterprises, will consistently feed accurate information on clinical trials into the new system.


On the European drug trial registry, compliance rates are lowest for small pharmaceutical companies, which typically lack specialised staff familiar with disclosure rules and procedures.


The policy brief recommends that the European Commission take ten simple steps to secure strong compliance and data quality from the very first day.


The proposed steps include creating a public dashboard that shows which companies are reporting trial results on time, and sending prompts to companies that fail to upload information as required.


FRAGMENTED DATA ON MEDICAL DEVICE TRIALS


A 2019 policy paper by HealthWatch UK warned that the new EU Medical Device Regulation, which sets out the parameters for Eudamed, could further undermine the evidence base on medical device trials because it does not explicitly require device studies to be registered on a WHO-recognised trial registry. (See page 16-17 here.)


Absence of clear and well-communicated rules about medical device registration and reporting in Europe could lead to confusion among companies and widespread failures to make trial results public.


Eudamed could also make finding information on device trials even harder than it already is. The European trial registry EudraCT only accepts drug trials, so information on medical device trials run in Europe is already scattered across multiple WHO-recognised registries, including ClinicalTrials.gov, ISRCTN, the German DRKS and the Dutch NTR – and that is before Eudamed enters the mix.


There seem to be no plans to integrate Eudamed into the global clinical trial registry system run by the WHO. Thus, companies will have to register and report each study twice on completely different systems, which is likely to be confusing, time-consuming, and lead to widespread data gaps.


The policy brief by Health Action International and TranspariMED also covers the new European drug trial registry CTIS. It can be downloaded here:




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