Using Patient Reported Outcomes in Dermatology Trials

ACT: Specifically in dermatology trials, which provide a lot of unique challenges, could you discuss some of the best practices for navigating the use of patient reported outcomes in them?

Mooney: As I mentioned earlier, dermatology is definitely an area that is going to leverage clinical outcome assessments (COAs) in their strategy. So whenever we see a dermatology protocol come our way, we know that most likely that COA strategy in the protocol is going to include, first of all, high volume; a lot of different questionnaires. And that can be challenging for a vendor because it increases the time we need to build and set up the study. And given that a lot of those questionnaires require licensing; licensing to use the assessment electronically, procuring the license can be a challenge in electronic clinical outcome assessment (eCOA) setup, because we are basically at the mercy of the copyright holder and being able to get that that license. So what we do to try to mitigate just the breadth of the COAS that are being used in dermatology studies and the licensing requirements is, again, we leverage an eCOA library where we've worked with the assessment owner to have available off the shelf and our library, the electronic version, also being able to establish the collaboration with the owner to perhaps create an MSA so that we can expedite the licensing of those assessments electronically, is one way we get away from the timeline challenges.

I think another challenge with dermatology studies is patient compliance. So given the emphasis and the prioritization of COAs in these protocols, usually the patient is required to complete a lot of assessments throughout their participation in the study. And a lot of that is done daily. So what we need to do is really leverage the technology to help drive that compliance. And that's the beauty of eCOA in this type of a situation is that we can use the reminder notifications on the device to drive compliance, we can create reporting windows so that data is being collected when it should be collected. Furthermore, once that data is collected, we know in these trials, it's important that the clinical sites and the study team have real time access to that data. So we need to make sure that we have the ability to create custom reports that are easily accessible to the study team and the site so that they can have oversight of the compliance of the patient, so if there is an issue, we can correct it early on.

So at the end of the day, we're really doing whatever we can within the COA solution to drive the endpoint integrity and protect that data collection. So we said compliance and the breadth of the assessments, I think those are the two main challenges in the dermatology space.