In November, I attended the second meeting of the Patient Engagement Advisory Committee (PEAC). I can only take so much time "inside the bubble," and I attended a lot of regulatory meetings in 2017. This year I was inclined to attend none, but the PEAC meeting was easily the most interesting of the lot, and finally I couldn't pass on attending the second one, to see how things were progressing.
A few general observations:
I was especially interested to see who showed up for the second one, since the first anything always draws people who are more curious than committed. My impression was that the overall turnout was a bit smaller than last year, but still respectable. I thought the digital crowd was less in evidence…perhaps smaller, or maybe just quieter…and that those who showed up this time seemed a bit more in touch with the actual "real world." The patient advocacy crowd seemed more in evidence, which I hope is a good thing. The registry crowd was pretty lightly represented, I thought.
Given this is a CDRH device advisory committee, not an ACRP advisory committee, I was relieved to see that the industry representative was now from the medical device industry. I know, you would think, right? But no...at the first meeting, it was someone from the CRO industry. How that happened, I don't even want to know.
Because many of the issues raised by the efforts to link patient engagement to the postmarket surveillance of device safety are statistical issues, I was not pleased to realize that none of the Committee members is an epidemiologist or a statistician, but maybe that too will change, next year.
I also realized that the methods followed in a traditional clinical trial came out of years of struggling with how to wrest some kind of meaningful (i.e. scientifically valid) result from "real world" evidence. I began to wonder if the ultimate result of all of this deliberation might not be the realization that the answer to these questions is.....a clinical trial. But we'll see...
[To be continued]
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------