TRANSPARENCY IN MEDICAL DEVICE CLINICAL STUDIES – THE FUTURE IS NOW

The era of full clinical data transparency is here,
and that includes medical devices: EMA issued their policy on the publication of clinical data effective as of the beginning of this year, and is currently requesting feedback on the application of the transparency rules of the EU clinical trial regulation, addressing medicinal clinical data.
Although generally speaking medical device study policies and regulations tend to be behind on the ones for medicine, for sure this will not be the case this time: The FDA/ NIH proposals on publication of clinical study results of studies registered at ClinicalTrials.gov includes medical devices, and – as I previously blogged – the current version of the EU MDR has strong elements on clinical data transparency similar to EMA.
Furthermore J&J recently announced that they will make their clinical data of approved devices available to the public.
To read the article by Annet Muetstege