Most discussions about the lack of diversity in clinical trials are focused on studies for drugs and biologics, not much is discussed publicly about the diversity of trial participants in medical device clinical trials. This week the FDA started publishing the “Device Trial Participation Snapshots” which shows important demographic trends for medical device clinical trials. Sponsors of medical device clinical trials might get some useful pointers from these snapshots.
Medical device clinical trials are required for all high-risk Class III medical devices, and a significant number of moderate-risk Class II devices. Although clinical trials for drugs and biologics account for a majority of all clinical trials, a significant number of medical device clinical trials are also conducted in the US in support of market approval applications. And unlike drug trials where most pivotal trials are multinational, medical device trials are conducted are mostly at US clinical sites only. The Device Trial Participant Snapshots are similar to the “Drug Approval Snapshots” that have been published by the FDA for the last decade. These snapshots are an invaluable resource to summarize key demongraphic information about the trials conducted in support of newly approved products. For drugs and biologics, these snapshots have shown the lack of diversity of trial participants which in turn has fueled efforts to address the same. The device snapshot shows a similar, perhaps even stronger trend of the lack of diversity in device trials.
At its inaugural release, snapshots are available for only 4 devices (although the list contains 5 devices, one of links was non-working at the time of this writing). For all of these devices, almost 80% of the participants were white, non-hispanic males. This is very small dataset but it shows similar trends as the drug and biologic trials in terms of the lack of diversity. Since medical device trials are almost exclusively conducted in the US, the device trial participant data is a better representation of US trial participants overall.
It would be unfair to read too much into participant diversity from this small dataset. The Center for Devices and Radiological Health (CDRH) intends to publish participant snapshots for all Class III medical devices approved via the PreMarket Approval (PMA) pathway and might expand all approved devices in future. Each year FDA approves about 20-40 Class III medical devices. In the same time period, the FDA approves about 3000 Class II medical devices. About 10% of Class II medical devices require clinical trials for clearance, so each year about 300 medical devices are approved by the FDA based on clinical trial data. Once more data is available, we might get a better picture of demographic diversity in medical device trials. That said, it is safe to say, that the lack of diversity seen in clinical trials for drugs and biologics, is probably true for medical devices as well, if not worst.
