SCOPE 2024: Todd Everhart of Signant Health Discusses DCTs and Site Burden

Applied Clinical Trials: What have been some of the biggest changes you’ve noticed in the decentralized clinical trial (DCT) space since the height of the COVID-19 pandemic?

Todd Everhart: I think the biggest change is just a realization that the target we were aiming for, particularly influenced by the urgent need at the time of the pandemic may have shifted on us. We did a lot of decentralized trials for lack of a better term. During the pandemic, we used a lot of decentralized tools and methodologies. And we started to collect data about the effectiveness of that, but we spent a lot of the time asking possibly the wrong questions. The example would be: are you using more telemedicine since the pandemic? The answer is yes, everybody's using more telemedicine. And so we check that off as a success for DCTs as proof that DCTs work. And that's not necessarily the same thing as asking questions like, now that you do more telemedicine, do you find it to be as effective as an on-site visit? Do your clinicians enjoy using telemedicine? Do your patients enjoy using the telemedicine? And there's more data coming out now that starts to answer those questions. And it puts a different picture on some of the decentralized methodologies when we find out that if given the opportunity, both patients and investigators would prefer to have an on-site visit if given the choice, or finding out that sites that employ a lot of telemedicine actually have an increase in after-hours workload compared to sites that don't do as much telemedicine. So, if you only asked, are you doing more as a sign of success, we may be missing the real story. And that even though we're doing more, is it really improving the efficiency of clinical trials? Are we possibly introducing more burden than we were before?

ACT: While DCTs have reduced patient burden, do you think that burden has moved elsewhere within the operation of a trial?

Everhart: Yeah, I don't believe we've actually removed an ounce of burden from the system with decentralized trials, I think we have in our effort to decrease patient burden. And I think we've been successful in that. And most of the tools and methodologies that are really focused on the patient; decreasing the amount of time spent on site, the ability to provide data remotely, even reading their consent before they come in, all of these things have gone in the direction of the patient and decreasing patient burden, which obviously has an upside by increasing participation, improving compliance, and improving retention; those are all great things. But I don't think we actually remove that burden from the system, I actually think we've shifted that burden to the sites. And I think we're starting to hear the sites push back now about the amount of burden that decentralized methodologies are now placing on them instead of the patient without actually removing the burden from the system.

ACT: What do you think are the biggest challenges in DCTs industry needs to address in 2024?

Everhart: One of those would be the site burden, paying attention to site burden and what we can do to alleviate that, or at least rebalance site burden. These technologies should be helping, they should be making trials more efficient. But when we push things out quickly, every solution creates a new problem. And so the solutions that we put in place to help patients may have created new problems with the sites and that’s something we have to be cognizant of. And then we have to develop the solutions to balance that out. I think the other is with all of these solutions. And again, what does affect the site is just the sheer volume and velocity of the data we’re creating. We're collecting more data than ever, we're collecting data remotely, somebody has to keep their eye on that. And just the cacophony of alerts and alarms and signals coming to the site's investigators on a daily basis from the ePRO platform and updates about the shipment of product to patients and there’s just so much data coming into a site at any given time. Being able to filter through all of those alerts and bubble up what's really most important, I think is going to be one of the bigger challenges and I'm hopeful that we can find creative ways to filter through those alerts; separate out the really important from the not as important to the maybe not important at all, and then I also think we need persona-based alerts. Not everybody on the team needs to know about every alert. Some alerts really need to be seen by the clinician. Some alerts need to be seen by the coordinator. Some alerts may need to be seen by the pharmacist. And being able to have those persona-based alerts I think would really be something that would help address some of that site burden.