The COVID-19 pandemic accelerated many aspects of clinical research.
Vaccines were developed and received the FDA’s green light in record time. Remote technologies were deployed to keep trials going, even when patients were no longer able to appear onsite.
It’s this second development that speaks to the possibilities that decentralized trials offer. Whether fully decentralized or some hybrid model, having a clinical trial untethered from geographic limitations opens the door for whole new populations of participants.
“The industry has had to turn to telehealth and remote patient monitoring now more than ever before, and we can only expect this to continue even after COVID-19,” says Isaac Rodriguez-Chavez, senior vice president of scientific and clinical affairs at the CRO PRA Health Sciences.
We’ll take his point one step further. Those changes won’t merely continue; they’re irreversible now.
As mdgroup COO Christopher Kennedy notes, the three biggest barriers for patients to onsite clinical trial participation have always been travel distance, the associated costs of participation and awareness of the trials.
Decentralization can help patients overcome each of those barriers in some way. Below are three reasons decentralized clinical trials — some of which are at least hybrid decentralized trials — can improve patient recruitment.
Decentralized Trials Reduce the Burdens of Patient Participation
Incentivizing patients to participate in a trial helps offset the burdens of travel, taking time off work, time away from family, and other such challenges. However, incentives can also bias results.
Decentralizing at least some of the trial provides a different, often better, way to offset the burden of participation.
For one thing, this helps overcome the travel issue for many participants, some of whom have to drive one or two hours each way to the trial site. By giving people a chance to participate from home, trials are made available to a much larger patient pool.
Carsten Sommer at Medgate AG in Switzerland was the lead author on a 2018 paper that explored whether a decentralized study could improve patient enrollment numbers. In the pilot program that Sommer et al. conducted, patients with lower back pain were enrolled in a study that split the group into either onsite participants or remote participants.
Though the sample size was small, the researchers did note that the remote study saw a notably higher representation among people from rural areas. In other words, making participation easier for some patients made a difference in whether they enrolled.
But it’s not just patients who live hours from a research site who benefit from remote trials. Patients with certain life-changing conditions might have trouble committing to a travel schedule.
Take ALS, for example. “An ALS diagnosis can be all-consuming and devastating for patients and their families,” writes Amy Raymond, the director of therapeutic expertise at the Center for Rare Diseases at PRA Health Sciences. “... ALS places emotional, mental, and financial burdens on patients and their loved ones.”
The very idea of patient-centricity in clinical trials is to address such patients, and to make research accommodate their needs.
Decentralized Trials Make Participating A Possibility for Some People
Building on the points above, accessibility means more representative population segments in trials.
As researchers Sean Khozin and Andrea Coravos note in an April 2019 article, in-home and remote monitoring makes trial participation possible for older patients, patients who couldn’t afford to miss work to participate, and “patients with comorbidities for whom clinical trial participation can be particularly challenging.”
What this means is better representation in each trial. As the COVID-19 vaccine trials showed the world, it’s important that the communities most impacted by a disease are represented in the search for a therapy.
Artificial intelligence has useful applications on this front. AI can help researchers circumvent the inherent biases that can cause people of a certain gender, race or ethnicity to be excluded from research. What’s more, AI can be useful in identifying trial candidates who are most likely to benefit. It can also be useful in identifying candidates who are more likely to drop out midway through the trial, which industry data suggests represents about 3 in 10 participants.
Decentralized Trials Open New Avenues for Patient Engagement
Finally, decentralizing trials can help get participation opportunities onto people’s radars. After all, many trials fail to enroll a sufficient number of patients simply because people don’t know about the trial.
“While extended hours, virtual visits, and better care will help with recruitment and retention, patients still need to be aware of clinical trials to consider taking part in them,” Clinical Leader’s Ed Miseta writes. “Unfortunately, many are not aware they exist.”
This is especially true for younger would-be participants. As Kent Thoelke, executive vice president and chief scientific officer at PRA Health Sciences, writes at STAT, nearly half of millennials don’t have a primary care doctor. By contrast, more than 80 percent of people 50 and older do.
This is important because primary care doctors are often the people who refer patients to clinical research. “[P]rimary care doctors are the most relied-on source for recruiting participants,” Thoelke writes. “If many of those in the largest living adult generation have no trusted relationships with primary care physicians, where and how will pharma conduct recruitment for trials?”
A decentralized trial, unbound by geography, is better-placed to use tactics such as digital advertising to connect with potential patients, thereby solving the primary care doctor problem.
Certainly, decentralization isn’t a cure-all for poor recruitment, nor is decentralization applicable to every type of trial. Some patients will have to make the trip for some trials for the foreseeable future.
But it’s a model that holds tremendous promise. As more people are offered more opportunities to participate in research, sample sizes become more representative, more trials are completed, and the science behind the whole pharmaceutical industry is bolstered.