AbbVie’s Director of Clinical Study Patient Platforms on Supporting Patients in Decentralized Trials
The Director of Clinical Study Patient Platforms at AbbVie, Anthony Taylor, walks us through how he evaluates what technologies to bring into clinical studies and dispelling misconceptions study teams have around decentralized clinical trials (DCTs) patient burden.
What are you focused on at AbbVie?
My focus is to bring new decentralized clinical trial capabilities to AbbVie and to our patients that are participating in our clinical trials for better access to trials remotely, with a focus on diversity and access. We evaluate all of the end-to-end capabilities that come along with DCT, such as e-consent all the way through things like mobile nursing at patients’ homes. We’re judging how beneficial it is to the study based on the maturity of the technology, how user-friendly it is, and what information we can collect from it.
We’re building all of our capabilities into a mobile application that can be used by the patient and the sites to make the trial experience more seamless and provide a menu of options for our study teams to choose from. Once the app is downloaded onto either the patient's phone or provisioned device, they have access to all of the trial activities.
What is the attitude you’ve seen from study teams about DCTs after the pandemic?
We want to enroll the patients that we need to in the study, but we also want to make sure that we're getting the most information that we can that's beneficial and required for that study. We’re not just focusing on one aspect of a trial; we’re looking across the entire trial to identify where we can implement a capability that will reduce time and burden for patients, sites and internal study teams. As an industry, we are also getting better at the standardization of DCT capabilities.
"We’re building all of our capabilities into a mobile application that can be used by the patient and the sites to make the trial experience more seamless."
How are you giving your study teams at AbbVie access to decentralized components?
We spend a lot of time with study teams identifying specifically what it is that a DCT capability can bring to the study: what are the benefits to the patients? What are the benefits to the sites? How can this improve communications with our internal stakeholders on the study teams?
If we look at a study with 30 visits on site, and we’ve learned from previous studies that patients end up dropping out because they can’t make all the visits, my team and I will step in and say, “We can reduce the travel burden or time on-site for patients at some of these visits by making them virtual, or in some cases even eliminating the on-site visit altogether.”
What is the biggest change in attitude you’ve noticed around study teams’ understanding of DCTs?
In the beginning, there was the thought that if you’re not asking patients to come in, it’s not burdensome. For example, if a patient would have to go into the clinic a few times a week to complete an assessment that could be done remotely, a DCT alternative would be to have those assessments done at home. But if they’re being asked to do it daily, that’s still a burden on them. Then it’s about figuring out if we can reduce a daily assessment to 2-3 times a week, and still get the same results.
Additionally, sites were also being burdened because there was an attitude of “If this is going to be remote, you can see more patients, right?” Now you're overburdening the sites with the expectation that they'll see more patients, but you're really not giving them the opportunity or time to really evaluate those individual patients.
"We’re looking across the entire trial to identify where we can implement a capability that will reduce time and burden for patients, sites and internal study teams."
Because there can be additional cost, how did you approach any sort of DCT capability?
It’s a balance between cost and utility. For example: we were interested in including gamification in the app. Gamification is used to keep the patients engaged and retained in a study, allowing them to participate without it seeming like a task they have to complete or a burden. It may seem like a nice-to-have but it does add a layer of engagement with the patient that can be very beneficial in the long term. Patients might say, “I really enjoy participating in that study because it was more than just me getting evaluated.”
But you have to consider whether the cost of building it out is worth the benefit. It may not be for all studies, because the budgets vary. If we have to make a decision between adding gamification and another visit to the study because they have to do a blood draw, the budget goes towards what is more critical to the study.
What challenges have come up in putting DCTs into studies that you’ve had to work through?
Something that’s come up is that some sites have begun to develop their own DCT capabilities, and one concern is about whose technology we will use. Will it be ours, that we developed specifically for this study, or will we allow sites to use the technology that they have, and are more familiar with?
We usually resolve that because sites are oftentimes amenable, especially if they have worked with the vendor before, and they're familiar with the system. Ultimately, we want to make sure that the technology is consistent across the sites. But it is a conversation we’re open and willing to have with sites once we engage them about conducting a DCT.
"What are the benefits to the patients? What are the benefits to the sites? How can this improve communications with our internal stakeholders on the study teams?"
What would you like to see more of across the industry when it comes to DCTs?
As we mature, we have to keep our lines of communication across industry open. We’re here to compete on product, not on technology, because we’re not technology companies. So we should continue to collaborate on the use of technologies to understand what does or does not work. In the end, we’re all just trying to enhance the patient experience.
