Recruitment for Parkinson’s disease is uniquely challenging, in part because in-person visits are so burdensome for participants. “Remote, decentralized studies shift research from the traditional clinic setting into the home, potentially making research more accessible and more convenient,” says Ruth Baciewicz Schneider, MD, senior instructor of neurology at University of Rochester School of Medicine and Dentistry.
Schneider and colleagues compared recruitment processes of three different remote, decentralized Parkinson’s disease clinical trials that used video visits.1 In those three studies, 706 participants enrolled at a mean per study rate of 4.9 participants per week. Participants reported interest in participation in future decentralized studies with remote video visits. “Remote, decentralized studies allow for the recruitment of large, geographically dispersed cohorts from a single location, and this design is well-liked by participants,” Schneider says.
In considering whether to use a decentralized design or to include remote assessments, the research team must determine if these methods can adequately answer the question under study. The study cohorts were demographically homogenous in terms of race (more than 95% of participants were white) and education level (more than 90% had earned more than a high school education).
“More research is needed to determine best strategies for improving recruitment with particular attention to the recruitment of groups underrepresented in research,” Schneider says.
Only a small proportion of people with Parkinson’s disease participate in clinical trials. “There are a lot of reasons for it,” says Roy Alcalay, MD, MS, associate professor of clinical neurology at Columbia University Vagelos College of Physicians and Surgeons.
If someone is educated and lives near an academic center, the likelihood of participating in research is much higher than for disadvantaged people who live far from academic centers. “In some studies, maybe the people who are recruited are not representative of the actual population of people who have Parkinson’s,” Alcalay says.
The era of precision medicine presents some new challenges. Researchers are not just recruiting all people with Parkinson’s disease; they are looking for those with a specific genetic profile. “You are talking about a smaller population. How do you recruit them if you use the traditional means of recruitment and the 10 leading sites in the U.S.?” Alcalay asks. The answer lies in part with telemedicine. “With telemedicine, you can think outside the box in different ways,” Alcalay says. For example, in the NIH-funded VALOR-PD, people who learn they carry a specific gene variant through the direct-to-consumer group 23andMe are invited to join the large longitudinal study. Most of the people who participated in VALOR-PD could not participate in other NIH studies on the gene variant because they are geographically remote.
The AT-HOME PD trial involved former Phase III clinical trial participants and took another approach. Researchers gathered many clinical data from participants. Instead of letting all these data go to waste, researchers invited those participants into a longitudinal study that offered remote participation. “When people talk about diversity, there are different types of diversity. The studies overcame the obstacle of geographical diversity,” Alcalay says.
Researchers can contact people in more remote areas who are not necessarily seeking care at tertiary centers. “That’s excellent, because it opens up a lot more options geographically,” Alcalay says.
Thus, enrollment is faster. “Where they didn’t bring a lot of diversity is race and ethnicity,” Alcalay notes.
The percentage of non-white participants is less than 5% in all the studies. “This advanced technology allows us to overcome challenges of geography, but not necessarily underrepresentation of some underserved populations in clinical trials. More work will need to be done to overcome that,” Alcalay says.
It makes sense that if researchers choose a site in a primarily white neighborhood, chances are participants also are going to be primarily white. “But the studies suggest that it’s not just the location of the site that is the reason why the site primarily recruited people from a specific race or ethnicity,” Alcalay says.
There are multiple reasons why research access is limited for certain people. Some of those reasons are geographical, others are related to socioeconomic status. “Telemedicine solves the geographical problem, but not the others,” Alcalay says.
Remote recruitment does make study participation easier for people. It also helps researchers overcome the challenge of finding people with unique genetic mutations that are not found at a single site. One remaining obstacle is the continued need for in-person visits. “One of the challenges specific to Parkinson’s is that the neurological exam by telemedicine is clearly not complete,” Alcalay observes.
Neurological exams are not needed for all studies. Some investigations can be conducted solely with telemedicine. “The telemedicine studies can be a point of entry for those who are eligible and who are interested in a site visit study,” Alcalay suggests.
Another important development is the use of wearable devices. These give researchers data even without the need to examine patients on site. “Introducing wearables into study recruitment may overcome the challenge of not being in the same room as a participant,” Alcalay says.
Alcalay is principal investigator on PD GENEration. He and colleagues are recruiting people remotely for genetic testing and counseling.2 “It’s opened up the American map. We see people from all 50 states,” Alcalay says.
Some studies may offer hybrid options, where participants visit the clinic only to give biofluids, but follow-up is handled remotely. If studies involve people in more advanced stages of the disease, which makes a commute challenging, remote visits can be a game-changer.
Still, there is no circumventing requirements for drawing blood or spinal fluids. The same is true for a neurological exam, although wearable technology is a possible solution. “A neuro exam captures 10 or 15 minutes of the day, and the wearable devices give data 24/7,” Alcalay says.
However, researchers must put more devices in homes of study participants, and regulators must validate the technology to their satisfaction. One recent decision by the FDA offers insights into what regulators are looking for in this regard.3
The agency denied a request from one company for clearance of a virtual motor examination to be conducted using a wearable device. The FDA stated the wearable assessment did not capture patients’ relevant outcomes, and that it prefers “content that is more representative of daily life functioning.”
As expansion and safety validation continue, Alcalay says “the combination of the telemedicine evaluation and wearable devices can reduce a lot of the burden of clinical trials.”
REFERENCES
1. Myers TL, Augustine EF, Baloga E, et al. Recruitment for remote decentralized studies in Parkinson’s disease. J Parkinsons Dis 2022;12:371-380.
2. ClinicalTrials.gov. PDGeneration: Mapping the future of Parkinson’s disease (PDGENE). Last updated on March, 10, 2021.
3. U.S. Food & Drug Administration. Drug development tool letter of intent determination. DDT COA #000142.
Remote, decentralized studies allow for the recruitment of large, geographically dispersed cohorts from a single location. In considering whether to use a decentralized design or to include remote assessments, the research team must determine if these methods can adequately answer the question under study.
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