The COVID-19 pandemic has touched nearly every corner of health care, including clinical trials. The biopharmaceutical industry, long dependent on patients traveling to clinical trial sites for tests, procedures, and safety monitoring, are shifting to a decentralized model where certain aspects of a trial can be completed from home and their local community. This model has helped ensure patient oversight and data collection during the pandemic and is evolving into a permanent part of trial design.
New challenges, new urgency
Traditional clinical trials depend on participants visiting a site at fixed intervals for study visits. Such trials have been undertaken in the same way for years, but they come with some limitations. Not everyone can afford to take time off work to participate and practical barriers such as a lack of childcare can be a challenge. Difficulty traveling to sites can also make it hard for patients to stay engaged in trials, or for sponsors to attract a diverse pool of participants.
COVID-19 has amplified these issues by placing new restrictions on travel, in-person contact, and group settings. “It created an urgent situation,” says Vicky Eyre, UK Clinical Trials Operations Manager for Re:Cognition Health, a private clinic for patients with Alzheimer’s disease and dementia that also leads clinical trials for pharmaceutical sponsors. “In the midst of a pandemic, we had to ensure that people stayed enrolled [in trials], and that we could continue collecting data.”
In the face of these realities, organizations are embracing Decentralized Clinical Trials, or DCTs, which move certain aspects of trials into the patient’s home. Four key characteristics differentiate DCTs from standard, on-site trials: remote communication with patients via computer, smartphone, or tablet; direct-to-patient drug shipments; sensors that support remote data collection; and at-home visits from health care staff. Despite previous hesitation from some trial sponsors, the pandemic has forced the shift from site-based to fully decentralized or hybrid models. “COVID-19 really changed everything,” says Rosamund Round, VP of the Patient Innovation Center and Decentralized Clinical Trials at Parexel, an industry leader in clinical research and biopharmaceutical solutions. “DCTs and hybrid solutions are now viewed as essential, rather than nice-to-have.”
Practical and emotional benefits
At their core, DCTs leverage advances in technology to ensure trial quality and continuity. Wearables and other sensors provide sophisticated measurement of a wide range of health data — everything from heart rate and sleep patterns to glucose levels and blood pressure. Patient apps allow investigators to monitor patients remotely via video call as well as supporting administrative functions like appointment reminders and consent forms. But there are decidedly low-tech elements, too: drugs are sometimes delivered directly to a patient’s home via courier, and in a new twist on the house call, nurses undertake home visits to conduct tests like blood draws and to administer medication.
The result is a high quality-trial, but also a better experience for patients, many of whom are deeply concerned about safety. “These days, you don’t want to travel if you don’t have to,” says Alfred Samuels, who began receiving medication at home at the start of the COVID-19 pandemic. Alfred says that despite his initial concerns, the process has been seamless. “I’d worry that the package was going to be late, or that the quantity wouldn’t be right, but then you get used to it, and it just becomes part of the process.”
Remote trials also create a better experience for patients uncomfortable visiting hospitals or other health care facilities. “The clinical environment is just very daunting for some patients,” says Malini Raj, whose mother suffers from dementia and receives regular in-home care. “My mother tends to be much calmer when someone comes here [to her home]. It’s a more representative picture of her normal state.” Vicky adds that reducing or eliminating on-site visits, particularly for patients with cognitive impairments, also lessens the toll on caretakers. “When regular attendance [at a trial] is required, it can be a significant burden for patients, but also for their families.”
There’s also the simple reality that in today’s busy, complex world, time is a precious commodity. “I don’t think the convenience factor [of DCTs] can be overstated,” says Vicky. “For a younger population busy with work commitments, the ability to do remote follow up matters. Travel to a trial site can be difficult. And when the country was on lockdown, it was impossible.”
And despite perceptions that telemedicine is a cold, impersonal substitute for in-person visits, investigators have been able to form meaningful relationships with patients via phone and video. In fact, Vicky believes remote technology actually offers the opportunity to form deeper connections. “Telephone catch ups with patients that aren’t for data capture or formal assessments might take five minutes,” she says. “But a quick check in for them to feel like you really care — I think it’s really important.”
And Vicky imagines a future where DCTs help sponsors recruit a more diverse pool of trial participants. “People are working, they’re busy, they don’t have the ability to jump in the car or pay for the train,” she says. “Remote follow-ups would allow more individuals to participate. And when people have a good experience [in a trial], they’ll tell their friends.”
DCTs are here to stay
Of course, moving to a DCT model isn’t without challenges, particularly among populations less comfortable using technology. But Vicky says careful pre-trial discussions will help address these issues. “We just have to be very clear about how the trial is delivered, to make sure that patients are willing to accept technology.”
While the embrace of DCTs may have been driven by COVID-19, it is likely to become a permanent part of the landscape, says Rosamund. “Now that patients know it’s possible, we may see them asking to participate in trials from home,” she says. “DCTs will be here long after COVID-19 is gone.”
And that’s just fine with caregivers like Malini, who speaks on behalf of her mom. “When you understand what it means to be at home and how you’ll be supported, you can see that it makes sense,” says Malini. “You feel safer, and you feel better.”