Some 85% of people over 60 use prescription drugs, according to the National Center for Health Statistics (NCHS). Yet, older people are not well represented in clinical trials, the gold standard for testing the safety and efficacy of medications, the NCHS says. The Food and Drug Administration’s 2018 Drug Trials Snapshot Summary Report found that for 59 new drugs, only 15% of the 44,000 patients who participated in clinical trials were 65 or older. For neurology drug trials, only 3% were older adults.
An effort is underway, however, to make it easier for people to join some clinical trials. Rather than travel to a research center, patients participate from home.
“The overwhelming majority of research studies are not done at the convenience of a participant,” says Adrian Hernandez, vice dean for clinical research at Duke University School of Medicine, who studies ways to increase patient engagement in clinical trials. “They’re done at the convenience of an investigator. People come in and are donating their time, their efforts, their blood, their data.” Hernandez and colleagues are launching a trial for people 75 and older to examine whether statins can help prevent cardiovascular disease and dementia. Participants will be recruited through their health care systems and the study will take place in their homes.
“For older people, getting involved in a trial can be difficult — navigating the system, going from the parking lot to the clinic, and then being able to interact with whatever tools or technologies that we have sometimes is not as friendly for older people,” Hernandez says.
Why It Matters
Until recently, researchers frequently excluded older participants, who often are on multiple medications or have several medical conditions. The fear was that the results would be inconsistent or not apply to a general population. But that rationale does not make sense, says Steven Cummings, director of the San Francisco Coordinating Center, a nonprofit academic research organization.
“If your drug only works in the small portion of older people who don’t have any other problems or medications, then it will be irrelevant to the vast majority of older people,” Cummings says. The pharmaceutical industry has excluded older people “without any reason or evidence that this would be a problem,” and only by having older people in clinical trials can physicians know the drug’s real-world effects, he adds.
Researchers have recognized this problem of excluding older adults for years and are trying to address it. But even so, there are barriers, including the difficulty of travel for older adults. For example, Seventy percent of potential clinical trial participants (of all ages) live more than two hours from a trial center, according to the Deloitte Center for Health Solutions.
Cummings and other researchers at the workshop said that site-free trials would be cheaper and simpler, potentially yielding valuable medical advances more quickly.
New Home-Based Parkinson’s Drug Trial
Cummings is launching a new drug trial for Parkinson’s that would give older patients a way to participate in the research without having to travel.
“Patients with Parkinson’s have a very high risk of breaking a bone because they fall a lot,” he says. Very few get treatment to prevent fractures, because “there’s no evidence they would benefit,” he says.
Cummings’ new study, dubbed TOPAZ (Trial of Parkinson’s And Zoledronic Acid), will determine whether a treatment used for osteoporosis, Zoledronate, would help prevent fractures in Parkinson’s patients. The treatment is administered once intravenously and lasts two years. “If it works, it’s extremely convenient,” he says. He has found from previous studies that making enrollment easy for patients is crucial to their willingness to participate. With TOPAZ, patients will be identified through their health system, the Parkinson’s Foundation or other trusted sources.
“We’re making it really simple,” he says. “They go to a website and if they qualify, a nurse will come to their home and give them an infusion of either the drug or a placebo. That’s it.”
Lower Cost, Less Time
Cummings’ team aims to recruit more than 3,500 Parkinson’s patients 65 and older, making it the largest study done on people with the disease, he says. “It doesn’t matter where you live, you’ll be able to join the study,” he says. Recruitment will be rolled out by region, beginning with the Carolinas.
Had the trial been done the traditional way, Cummings says, it would likely involve 100 clinics to recruit 3,500 participants, each staffed by nurses, technicians and research assistants, and taking far longer.
“From conversations with colleagues in Pharma (the pharmaceutical industry), they roughly estimated
thirty five thousand dollars to fifty thousand dollars per participant for five years, not including employees who support trial functions,” Cummings says. “TOPAZ costs nine thousand one hundred and fifty dollars per participant, including all coordinating center staff support.” The National Institute on Aging awarded TOPAZ researchers a $32.6 million, five-year grant for the study.
One Size Does Not Fit All
However, researchers caution that there’s no one best approach to clinical trials. Some participants may actually prefer to go to a research site. Hernandez notes that patients may not remain as engaged if they are participating from home. “With an in-person trial, there’s a strong relationship with the study team, and retention is higher than virtual studies, at least so far,” he says.
There are also equity concerns regarding technology that may be needed for home-based trials. Although 81% of U.S. adults own smartphones, just 53% of people 65 and older do, according to the Pew Research Center. Older people are also less likely to use the internet, according to the National Academies of Science workshop.
Researchers shouldn’t assume that adequate bandwidth is universally available and affordable, says Silas Buchanan, CEO of eHealth Equity, a for-profit company connecting underserved groups with health information.
“Those are real obstacles, and that leads us into a conversation about social determinants of health, where people live, work, play and pray, age and die, and whether or not they are in a position to participate, even though they may want to,” Buchanan says.
Call to Action: Interested in participating in this new home-based Parkinson’s drug trial? Patients with any disease can search for clinical trials online at ClinicalTrials.gov. You can also see enrolling clinical trials by signing up for Trialsite News’ Daily Digest.