Clinical Trials Are Moving Out of the Lab and Into People’s Homes
After the pandemic forced thousands of trials to shut down, researchers found clever ways to conduct human studies remotely — while reaching more people, quickly and cheaply.
When the pandemic hit last year, clinical trials took a hit. Universities closed, and hospitals turned their attention to battling the new disease. Many studies that required repeated, in-person visits with volunteers were delayed or scrapped.
But some scientists found creative ways to continue their research even when face-to-face interaction was inherently risky. They mailed medications,performed exams over video chatand asked patients to monitor their own vitals at home.
Many scientists say this shift toward virtual studies is long overdue. If these practices persist, they could make clinical trials cheaper, more efficient and more equitable — offering state-of-the-art research opportunities to people who otherwise wouldn’t have the time or resources to take advantage of them.
“We’ve discovered that we can do things differently, and I don’t think we’ll go back to life as we used to know it,” said Dr. Mustafa Khasraw, a medical oncologist and clinical trial specialist at Duke University.
According to one analysis, nearly 6,000 trials registered on ClinicalTrials.gov were stopped between Jan. 1 and May 31, roughly twice as many compared with non-pandemic times.
At Johns Hopkins University, for instance, researchers delayed their investigation into how adults aged 65 to 80 metabolized tenofovir, a drug used to prevent and treat H.I.V.
“The idea of recruiting older people who we know are particularly vulnerable — recruiting them to answer a fundamental question that is not going to immediately change care or impact their health — just seemed like not what we should be doing,” said Dr. Namandje Bumpus, the pharmacologist leading the study, which remains on hold.
In Flint, Mich., researchers had to stop enrolling emergency-room patients for a hypertension trial. Other volunteers quit the study or became difficult to reach.
“Their phone service has dropped or they have very different schedules or they’re harder to reach because they’re caring for someone,” said Dr. Lesli Skolarus, a stroke neurologist at the University of Michigan who is leading the study.
Dr. Skolarus and her colleagues kept the trial going, albeit with some modifications. Most notably, they scrapped their in-person follow-up visits, instead asking participants to use take-home blood pressure cuffs and to send photos of the readings via text message.
Other research teams made similar adjustments.Neurologists at Massachusetts General Hospital in Boston revamped a pilot study of methylphenidate, the active ingredient in Ritalin, in seniors with mild dementia or cognitive impairment. Instead of going to the hospital every two weeks, study participants are now receiving their medication by mail, taking cognitive assessments over video conference, playing brain games on their computers, and completing daily surveys at home.
“Essentially, this is now a totally virtual trial,” said Dr. Steven Arnold, the neurologist leading the trial.
Even when scientists can’t eliminate in-person visits, they’re finding ways to reduce them. When Lorraine Wilner, a 78-year-old retiree with metastatic breast cancer, first began a clinical trial at Duke University last summer, she had to make the three-hour drive to the Durham, N.C., campus every four weeks, for blood work and occasional other tests. She said she would always leave with a full gas tank, “so I don’t have to stop at a gas station or touch things or go into places where half the people don’t have a mask on,” she said.
But she can now have her blood drawn at a lab near her home in Lancaster, S.C. Researchers then review the results with her over a video call.She still has to drive up to Duke for periodic scans, but the reduced traveling has been a great relief. “It makes it a lot more convenient,” she said.
Remote trials are likely to persist in a post-pandemic era, researchers say. Cutting back on in-person visits could make recruiting patients easier and reduce dropout rates, leading to quicker, cheaper clinical trials, said Dr. Ray Dorsey, a neurologist at the University of Rochester who conducted remote research for years.
In fact, he noted, enrollment in one of his current virtual studies, which is tracking people with a genetic predisposition to Parkinson’s, actually surged last spring. “While most clinical studies were paused or delayed, ours accelerated in the midst of the pandemic,” he said.
The shift to virtual trials could also help diversify clinical research, encouraging more low-income and rural patients to enroll, said Dr. Hala Borno, an oncologist at the University of California, San Francisco. The pandemic, she said, “does really allow us to step back and reflect on the burdens that we’ve been placing on patients for a really long time.”
Virtual trials are not a panacea. Researchers will have to ensure that they can thoroughly monitor volunteers’ health without in-person visits, and be mindful of the fact that not all patients have access to, or are comfortable with, technology.
And in some cases, scientists still need to demonstrate that remote testing is reliable.While Dr. Arnold is optimistic that in-home cognitive tests could provide a better window into his patients’ everyday functioning, he noted that homes are uncontrolled environments. “Maybe there’s a cat crawling on them or grandchildren in the next room,” he said.
There is also the unpredictable nature of human behavior. Dr. Brennan Spiegel, a gastroenterologist and the director of health services research at the Cedars-Sinai Health System, frequently uses Fitbits to monitor trial subjects remotely. But a participant once put the device on a dog. Several others sent their Fitbits through the wash. “You get a lot of steps all of a sudden — thousands and thousands of steps,” he said.
And some treatments simply may not work as well at a distance. Last January, Clay Coleman Jr., a 61-year-old Chicago resident, enrolled in a clinical trial to treat his peripheral artery disease, which caused intense pain whenever he tried to walk. “It was very hard,” said Mr. Coleman, who doesn’t drive. “My legs are very important to me because that’s how I get around.”
He hoped that the trial — which involved taking a blood pressure medication and participating in a supervised exercise program — could get him back into walking shape. Three times a week, he traveled to a local gym for a structured treadmill workout with a coach.“I had been there maybe six weeks or so before this virus thing came around,” he said.
Suddenly, the gym was out. Instead, Mr. Coleman’s coach called him regularly on the phone and encouraged him to keep moving.
Dr. Mary McDermott, ageneral internist at Northwestern University who is running the trial, isn’t sure how effective this kind of remote coaching will be. “We cannot assume that remote interventions are going to be the same,” she said. “Or that remote measurements are going to replace everything that we have done in person.”
Still, the pandemic has demonstrated that there is room for reform. Dr. Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston, is part of a team starting a trial of an injectable blood thinner later this year. After the first, in-person medical visit, appointments will be virtual.
“I’m quite sure if Covid had not occurred, we would have done things the usual way,” he said. Sometimes, he added, “it takes a crisis to provoke change.”