Increasingly savvy patients call for shift in trial approach: Illingworth
Thanks to a number of factors—outreach efforts, media coverage, visibility into the development of COVID-19 vaccines—the public is increasingly cognizant of clinical trials, how studies work, and the benefits of participation. Gerard Baron, vice president of operations with Illingworth Research Group, spoke with Outsourcing-Pharma about how an increasingly educated patient population has affected what they expect of the study experience, and how trial teams should adapt.
OSP: How can a patient’s level of familiarity with the way clinical research operates impact their experience and the data collected?
GB: Well, the more a patient understands the goal of a clinical trial—and the value of their own role in it—the more likely they are to be engaged and compliant, and the more likely they are to stay enrolled throughout the duration of the trial. Obviously, compliance and retention are both essential to good overall trial data.
One way to boost patient engagement is for patients to take a more active role in the data collection itself, to feel like a participant in the research, as opposed to a subject of, or worse, a mere number in it.
OSP: Does this vary with on-site trials versus decentralized studies?
GB: Yes, on-site trials and decentralized studies have very different levels and natures of patient engagement. Remote digital technologies, such as wearables and other mHealth devices, are driving change because for the first time patients can actually see how their behavior affects their health in real time. That can be very powerful.
Their devices capture everything from heart rate to blood oxygen level to far more esoteric measurements, and instead of the reading being taken by a technician and simply entered in their record, the patients are directly involved. For studies on disease states with a strong behavioral component, that can be transformative. Recently, clinical trial staff have been taking a much closer look at how to manage and incorporate data collected by patients—both self-reported and through personal devices.
OSP: Has COVID-19 and the publicity about vaccine trials impacted patients’ awareness of trials, and the ins and outs of studies?
GB: Absolutely! I can’t tell you how many people had no idea what a clinical trial was a year ago. But now, having heard about trials in daily news cycles for more than a year, they understand the need for them, the goals of a trial, the need for patient participation—and that there may well be trials occurring around a disease state or health issue that they suffer from.
People know now to proactively ask their doctors if there might be a trial they should participate in. This trend should help overall trial recruitment. But, of course, a knowledgeable patient is also a savvy patient—one with expectations and demands. So, it works both ways, and we must be prepared to adapt and respond to more engaged patient participation.
OSP: Could you please talk about the difference in familiarity with how trials work between rare/orphan diseases and more common conditions?
GB: The rare disease community tends to be tight-knit and more self-informed. They rely less on the opinion of a single expert; they augment what they are told with their own research. A tremendous percentage of rare diseases present in childhood, and the desperate parents of these children turn over every stone in the search for hope of any kind. They trade information, not only about treatments but about the research that is being done.
So, they know about clinical trials in a broad sense, and they know about the mechanisms of specific trials. For instance, they know that Trial A is using remote monitoring or home visits—and they’ll want to know why Trial B can’t do that, too.
OSP: How might a trial team differ in their handling of a patient that is more knowledgeable, compared to a patient who comes in knowing less about trials?
GB: Certainly with the “rise of the savvy patient” a new approach will be required from the start. During recruitment, the trial team is going to have to enumerate the things they will do to make the trial easy for the patient—and minimizing or eliminating travel is a big part of that.
Squeezing in a clinical trial visit from somebody who rings your doorbell or comes to your school or work location and stays for an hour is a lot easier than having to take time off work or school, figure out childcare, and deal with transportation. Essentially, the trial team really needs to look at every aspect of their study through a patient-centric lens. And that’s true whether the patient is knowledgeable or not.
OSP: If a patient enters with specific expectations of how they’ll be treated, compensation, communication, etc., does that make things easier for sites and sponsors, more complicated, or just different?
GB: I imagine that many sites long for the days when they set the parameters and the patients complied. Yet, in some ways savvy patients make everything more straightforward; you know precisely where you stand.
We were involved in a trial with a large academic hospital. The first two patients who enrolled in the study dropped out because they didn’t want to have to stay at the site. That was a pretty clear message. Ultimately, we were able to keep them in the trial, because we brought the trial to them.
OSP: How is the rise in at-home trial operations impacting patient perceptions and expectations?
GB: During the height of the pandemic, sponsors were eager to find ways to keep patients enrolled in trials. With patients’ well-founded fear of contagion, both travel to sites and even visits to more local hospitals were more or less off-limits. So, sponsors sought mechanisms that enabled the patient to stay in their own homes.
Fortunately, technology provided, with a range of mHealth devices. Those were augmented by mobile research nursing providers who brought diagnostics and monitoring to the patients. Guess what? Patients preferred the convenience of not having to go to trial sites.
Now that they have experienced what is possible, patients increasingly expect it, pandemic or not. It’s not dissimilar, perhaps, to what many have learned about working from home in the course of the pandemic.
OSP: What advice would you offer any clinical research professionals in dealing with an increasingly savvy patient population?
GB: I think sponsors and trial sites have to face the reality that patient expectations have shifted. The industry has permanently changed; we aren’t going back to the way things were.
Bringing the trial to the patient can help retention. It’s not just about COVID-19 safety; there are economic burdens that patients shoulder when they have to disrupt their lives and travel to a site. Plus, patients are now interested in being more actively engaged with the trials.
Again, technology can help meet these new expectations. Of course, remote technology isn’t without issues. There are concerns around patient privacy, as well as data integrity and consistency across devices. And on the sponsor side, there is a question of new protocols, as well as increased expense for sites to manage data that is collected remotely.
OSP: What role do home health trial service providers like Illingworth play in helping address these challenges?
GB: Overall, the sponsors’ biggest concern about remote and decentralized trials is whether the data will be as clean as it would be coming from a site. The answer is: It can be. And mobile research nursing providers can play a large role in ensuring that it is.
Fundamentally, real-time-reporting wearables and home health nurses go hand in hand to enable continuous health monitoring. Often patients need help setting up wearables and apps accurately; mobile nurses can help with that. They can also mitigate concerns about data integrity by having standardized processes, synchronized SOPs, and ensuring that all equipment is uniformly calibrated.
Clinical trial sites aren’t going away, but mobile nursing will be key to bridging the need for professional oversight with patients’ desire not to be tethered to sites.