Real world data registries

[poppy.b]

Hi everyone, we have received a recommendation from our Notified Body regarding our clinical evaluation. Within the clinical evaluation we conduct literature search and also collect PMCF questionnaires and for data of higher level of evidence, we were recommended to search the real world data from data registries. I wanted to ask other manufacturers, have you set up your own database to collect these real world data or do you use any public registries? If so, which ones? We are manufacturer of active, non-invasive medical devices.

 

[yodon]

See if this thread helps.

 

[Al_Z1]

Hi. I guess, that databases needed depend on what do you want to find: @yodon gave quite useful link on the thread for different incidents and recalls of the devices (we used some of these databases for vigilance report part of clinical evaluation). But if you need clinical trials results as a support is better to use PubMed ClinicalTrials.gov https://www.cochranelibrary.com/.

 

[poppy.b]

Thank you for your replies. Forgot to mention we also search for incidents and recalls within our PMS and clinical evaluation. This was meant more like a real data about our devices from users. To have a better awareness about the indication, age and gender of pacients and progress after the therapies. We thought the customer questionnaires should be enough, but it is not such a high level of evidence since it's not collected in a organized way. Now we don't know, if we should set up our own database or if there are any public/national registries we could use.

 

[Al_Z1]

It seems to me, that your NB wants something like full clinical trials with your device.

 

[yodon]

It seems to me, that your NB wants something like full clinical trials with your device.

I am not reading that into any of this.

What I've seen in the past is to identify the databases searched and establish the search criteria as well as inclusion and exclusion criteria. For example, if I had a device with a particular FDA device code, say, BTC, I could search, for example, the MAUDE database for any reports against that product code. I may find that there are specific products that I can legitimately exclude and would note that. There may also be similar product codes I may want to include. I can then use the data to see if there are any concerns regarding my product.

I had one customer where we did a search like this, found that a competitor's product was having particular (systemic) issues. We used that data to determine if this issue *could* be relevant to ours. (Turns out it wasn't and we wrote up a report to that effect.) I think this is the intent - to take the blinders off and do a broad scan of what's going on in the field (the "real world") to see if there may be things you need to address.