Last week Glenis Willmott was announced to be the new rapporteur for the Medical Device Directive revision. For me that raised the question what effect this will have on the clinical research aspects of the proposed Medical Device Regulation. Given her interest and activities for the recently revised clinical trial regulation for medicinal products, an easy bet is that the focus will be on clinical trial transparency and patient safety. In the announcement she stressed:
“We must ensure the industry is transparent and works in the interest of patients.”
So what elements were incorporated in the clinical trial regulation under her supervision, and what of that is part of the current version of the MDR and may stay or change?
Public European database
Willmott is a strong advocate for full clinical data transparency through a publicly accessible European database guarded by the EMA. Under the revised clinical trial regulation this database is meant to register all clinical trials in Europe, and should include a lay summary of all trial results uploaded within 1 year after the trial ended.
The concept MDR is also striving for an EU database, to ensure that
“every clinical investigation is registered in a publicly accessible database”,
and the trial sponsor shall
“within one year from the end of the clinical investigation or from its early termination”
submit a summary of the results accompanied by a
“summary presented in terms that are easily understandable to a layperson”
In other words the concept MDR contains wording similar to that in the clinical trial regulation, and we can be pretty sure that this will be implemented, although the exact construction of this Eudamed database is still questionable.
The clinical trial regulation also aims to simplify safety reporting and allows for suspected unexpected serious adverse reactions to be reported in the EU pharmacovigilance database directly instead of submission to each EU Member State.
The concept of the MDR has a different phrasing in this respect:
“Sponsors should report adverse events occurring during clinical investigations to the Member States concerned”
Since many clinical trials nowadays have an international character, a change of the MDR towards the clinical trial regulation would certainly help making adverse event reporting easier and more consistent, and therefore be development for the good.
Clinical Study Report
Also for the sake of full clinical data transparency, the clinical trial regulation requires that all clinical trials and reports of trials used in a marketing authorization request are to be registered or published, whether the request is approved, rejected or withdrawn.
Again the proposed MDR contains very similar phrasing that
“Irrespective of the outcome of the clinical investigation, … the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation”.
The difference being that the current version of the MDR, differentiates between the different class of devices as it also says that
“A summary of the safety and performance report should be publicly available via Eudamed” in case of class III medical devices.”
So this also is a keeper in the final MDR, although it may become more stringent than it currently is.
Another field of Willmott’s interest relating to patient safety, concerns the fact that minors are underrepresented in clinical trials. This because the population is relatively small, the trials are complex, and the bureaucratic burden is high. The safety and efficacy profile of a product in an adult, however, cannot simply be translated to a child: A pacemaker has different requirements in size and settings in an adult than a child.
The new clinical trial regulation is anticipated to address these challenges with simpler and more uniform rules facilitating the execution of cross-border trials.
The proposed MDR contains a complete section addressing clinical studies in minors, listing the conditions that have to be met in order for them to be conducted. Indeed, looking for a more uniform approach across the EU borders, but I wonder whether this, especially in combination with the so feared scrutiny procedure, leads to a lessening of the bureaucratic burden and more paediatric trials. Maybe this is a piece in the MDR that will develop for the good under Willmotts supervision.
In conclusion, the effect Willmott’s appointment will have on the development of the MDR is hard to tell at this point in time. However, given her involvement in the clinical trial regulation and interests, we can expect that clinical research will get even more attention than it did under Roth Behrendt’s reign.