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Regulatory Compliance With eCOAs

ACT: Are there currently any regulatory challenges with the use of electronic clinical outcome assessments (eCOAs)? If so, how can they be addressed going forward?

Mooney: That’s a good question. And I am happy to say that I’ve been working in the clinical outcome assessment (COA) space for about 20 years now. And I think we are at a point in time where we can actually say, we no longer have to worry about that scrutiny from the regulators when we are collecting data electronically, and not using the old-fashioned traditional paper based data collection methods. And the reason for that is we’ve evolved so much with technology. We know that there’s such a focus on patient centricity these days and minimizing patient burden. And from that perspective, there’s research and surveys that demonstrate that patients prefer being able to use electronic modalities over paper, it’s just easier, it integrates into their daily routines, they don’t have to worry about carrying around a stack of papers, so regulators appreciate that. And more importantly, I think, we know from the guidance that they provided that they expect, when COA data is being submitted for regulatory review, you have to be able to provide evidence that it was collected in adherence to the ALCOA principles. So that means you can show that the data is attributable to who entered it, legible, contemporaneous, original, and accurate. And it’s so much easier to do that with an electronic system as opposed to paper. So in general, I think we don’t need to worry about the scrutiny from the regulators anymore, assuming the COA vendor is adhering to the good clinical practices for setting up a data capture system and adhering to all the global security and privacy regulations.

The only other point I would make about the regulatory considerations, I think, as technology continues to evolve, we are starting to see sponsors push the boundaries for how they would like to use it. And in the dermatology space, in particular, one thing we’re starting to see is sponsors have asked for: can you activate the image capture feature in your platform, so that when the patient’s completing a diary, if they report they have a rash or some skin anomaly, that they could take a picture and upload that picture so that it could support the clinicians review. And that makes perfect sense. And it’s great, and we have the tech to do it. And this is what sponsors want and need. But, I think as we start introducing more innovative features like that, we’re going to have to be very careful in that we could be opening the door for some more regulatory scrutiny if we’re not handling the management of that type of data in the right way since we don’t want to reveal any personal, identifiable information or anything like that. So, I think it’s all good and exciting stuff. But I just wanted to make that comment, as far as innovation and the regulatory view.