Clinical studies for medical device companies are different and the regulations to manage the studies are very different. However, if a medical device company plans on publishing their results in any major journal or for an abstract at a medical conference, they are going to need to get an NCT number. And that only happens when you register the study on ClinicalTrials.gov. As a result, more medical device companies are registering their studies on ClinicalTrials.gov than ever.
To date, Medical Devices registrations on ClinicalTrials.gov represents over 12% of all trials registered but if you look at the recent history, the increase in medical device companies registering is significant:
As you can see by the above graph, in 2015 the number of medical device studies as a percentage approached 18%. There are two factors driving this growth:
- FDA is currently more aggressive on the approval of medical devices and no longer accepting status quo (510k application). As the graph shows, this became apparent in the beginning of the last decade with a spike in 2005.
- The requirement of a NCT number for publication is the other major driver. Now most major medical journals and medical societies require a NCT number for both publication and even generating abstracts.
Are we seeing the growth in device clinical studies or just improvement in compliance with clinicaltrials.gov?