Closely monitored, decentralized trials have also been shown to improve electronic patient reported outcomes to 92% compliance, according to ObvioHealth.
Ivan Jarry, CEO of ObvioHealth, a company that designs and runs technology-enabled trials, joins Pharmacy Times to discuss how decentralized trials—or what he likes to call the digitization of trials—can solve many of the pain points that come with a centralized trial model. Jarry goes into depth about why it’s necessary to keep human elements in the trial, how technology can improve logistics to improve the on-site experience, and more.
PT Staff: What are some of the major drawbacks to centralized clinical trials?
Ivan Jarry: The pain points of the traditional clinical trial is recruitment and retention of patients because patients must travel to a site, it's burdensome for them. And, because you're limited in geography to recruiting people only around that site, it limits the population that you recruit from. Those are the 2 major pain points in a centralized, less traditional clinical trial.
PT Staff: Now, what are some of the pain points of doing a decentralized clinical trial?
Ivan Jarry: Technology can be an issue, especially when we say decentralized clinical trial, the vast majority of decentralized trial are still hybrid, meaning that there's a sites component involved, because some of the assessments can only be done at a site, or it's better to perform them at the site. And so you need to build it in a way that doesn't come you don't transfer the burden, extra burden of technology to the site. And I think that's 1 of the limiting factor of adaptation to that.
PT Staff: What are some of the ways that people are addressing these pain points [in decentralized clinical trials], or at least you and ObvioHealth?
Ivan Jarry: Sure. So, we try and see what the reasons are for a participant, or sites, to not be part of a clinical trial. For the patients, if you can remove the site visits, if you can make it easier for them to participate, you can stay at home, they can do things virtually as we're doing right now, it's more convenient. If they can receive their study on device or the drugs at home, they don't have to travel all that makes it easier for them.
Now, we need to look also at the site. If it's a hybrid study that needs time for some of the visits—you still need to go to the site—we would like to remove the burden from the site. It’s okay to do the assessment [at the site], that's what they are made for. But when dealing with the logistics (in the traditional model) the site would have to have a room, host, and study product. It would have to have an inventory, have a way to destroy the unused one. So, it's a lot of procedures and personnel that you need to train. If we can take care of the logistics, we will ship directly to the site. If the patient doesn't have to fill out informed consent and a ton of paperwork once they arrive— if they already do that at home with the supervision of a remote coordinator, for example, when they get to the site—there will be less burden on the site. So that's what we're trying to remove, the paperwork and the logistic aspect out of the site. Deal with it through our platform so that the site has more time to spend with the patient than dealing with the administrative paperwork of a clinical trial.
PT Staff: Thank you. And I'd like to take just a quick half step back. Can you explain specifically what decentralized entails in this setting?
Ivan Jarry: Decentralized is a word that is being used a lot and since the pandemic, so I think I like—or prefer—to talk about digitalization. I think it's more reflective of where the industry is heading. So decentralized mean that some components of a study will be done remotely. So, it could be most of the studies where we're seeing today, the consenting process is kind of depart that can be done on an app pretty easily. And the patient now can sign directly remotely the consent, but it's also some assessments can be done remotely through telehealth using connected devices or questionnaire on your phone. So all those components makes a study decentralized.
PT Staff: Could you describe how your clinical oversight and coordination hub (COACH) team, the people on the back end, are going to help participants monitor and successfully do the trial?
Ivan Jarry: COACH is our team of coordinators and clinicians that are helping the participants through the clinical trial journey and supporting our sites. Technology is great, but we are getting a fatigue of notifications and reminders on our phone. We discover very early on that if the first message you receive is from an actual individual versus an automated message, they say, “Oh, thank you for signing up and welcome to our trial.” But if it's a personality message to say, “Hey, my name is Poris. I'm going to be the principal investigator (PI) on that study. I'm available Monday to Friday from that to that time. If you have any questions and here my other colleagues that will be available to answer any of your questions.”
That makes that the compliance and retention of participants got a lot higher just by that initial contact by a human. What we do is the system triage the requests, and we look at the behavior from participants. And we will take our COACH team, “Hey, Be careful. Patient 103 has not responded to the questionnaire for the last 2 days, maybe you should give them a phone call.”
So our technology is enabling the COACH team to do more work and be more present in front of the patients because the system tells them, “Hey. This is who you need to pay attention to because that person may drop because they have not done the task for the last couple of days.” And that's the combination of technology and human that has been enabling us to have a 92% compliance in our electronic patient reported outcome (ePRO) and 88% average retention across all our studies.
PT Staff: It does strike me that you have to have that human element. What do you notice when people are entering these trials? How do they feel before going in? And how does having someone to walk you through help the process?
Ivan Jarry: It helps a lot. Some of those concepts first are complex. And you want to make sure that people understand what they're getting themselves into. Sometimes it requires 15 minutes a day. Sometimes—with parents with infants— you want to make sure that they understand what they're going to have to do at which moment and what's the commitment; you want to avoid them dropping out after a week or 2 because they can't do it. So you'd rather make sure they understood and have them drop before entering the trial, then starting the trial and then losing these are participating participants along the way. So that consenting process upfront is very important. We have a methodology where we can have what we call guided consent. So while the participant is reading the consent, we can have somebody on the television call that guide them and say, “Hey, did you read paragraph 3.2? Do you understand that you're going to need 30 minutes on Monday, Wednesdays, and Friday for the last 2 months to be able to do this.” And the boss says “Oh, yeah. Okay. Are you available? Or do you have somebody that can drive you to that site? Do you have a car to get there?”
Having this touch is very important, [while] understanding why the participants are in the trial. Some people are motivated because of the science. For some, it's because it's the only treatment available for them because they don't have a drug in the market. Some people, it’s the money, it’s incentive to people to access care for them, for example, in the reimbursement. So understanding what's the motivation help us keep those people on track along the way. The way it's done normally is the coordinator will go and say, “Hey, let's look at page 2. You understand this is the floor. Are you clear about that? And the guidance so we try to mimic that so we can do it virtually by we use quizzes, we use little summaries blurbs to make sure that people understood the section, but sometimes we have that live visits remotely where patients are being walked through the consent has, they would do in a traditional site where they will be sitting next to the coordinator.