Clinical Trials Are Moving Out of the Lab and Into People’s Homes

When the epidemic hit last year, clinical trials took a hit. Universities closed, and hospitals shifted their focus to fighting the new disease. Many studies were repeated, with volunteers delaying or scouring the person’s visit.

But some scientists found creative ways to continue their research when face-to-face interactions were inherently risky. He wrote medicines, Performed on video chat And asked patients to monitor their own vitamins at home.

Many scientists say that this shift towards virtual studies is long overdue. If these practices persist, they can make clinical trials cheaper, more efficient, and more equitable – providing cutting-edge research opportunities to those who might not otherwise have the time or resources to take advantage of them .

“We’ve come to know that we can do things differently, and I don’t think we’ll go back to life because we knew it,” Dr. Mustafa measles said, Medical Oncologist and Clinical Trial Specialist at Duke University.

According to an analysis, Registered on nearly 6,000 tests clinicaltrials.gov Were stopped Between January 1 and May 31, approximately twice the non-epidemic time.

For example, at Johns Hopkins University, researchers delayed their investigation into how adults between the ages of 65 and 80 metabolize tenofovir, which is used to prevent and treat HIV.

“The idea of ​​recruiting older people that we know are particularly vulnerable – recruiting them to answer a fundamental question that isn’t going to change care immediately or affect their health – just looks like Was what we should do, “Dr. Said Namandeju Kumpus, who is a pioneer on studies, who stays on hold.

In Flint, Mich., Researchers had to stop recruiting emergency room patients to test for high blood pressure. Other volunteers left the study or found it difficult to reach.

“Their phone service has fallen or they have very different schedules or are harder because they are caring for someone,” said Dr. Leslie Scolarus, a stroke neurologist at the University of Michigan. “

Dr. Scolarus and his colleagues continued the trial with some modifications. Most notably, they canceled their in-person follow-up visits, instead asking participants to use take-home blood pressure cuffs and send pictures of readings via text message.

Other research teams made similar adjustments. Neurologists at Massachusetts General Hospital in Boston conducted a pilot study of methylphenate, the active ingredient in retailin, 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, conducting cognitive assessments in video conferences, playing brain games on their computers, and completing daily surveys at home.

“Essentially, this is now a completely virtual test,” Dr. Said Steven Arnold, the neurologist who led the trial.

Even when scientists cannot terminate in-person visits, they are finding ways to reduce them. When 78-year-old retired Lauren Wilner, suffering from metastatic breast cancer, first began clinical trials at Duke University, she had to drive three hours to the Durham, NC, campus every four weeks for blood work. And sometimes 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 to places where half the people don’t have a mask,” she said.

But she can now extract her blood in a laboratory near her home in Lancaster, SC researchers then review the results with a video call. He still has to drive up to Duke for scans from time to time, but the reduced commute is much relieved. “It makes it more convenient,” she said.

The aftermath of remote tests is likely to remain in the epidemic era, the researchers say. Dr. Ray Dorsey, a neurologist at the University of Rochester who did remote research for years, said that cutting on in-person visits makes it easier to recruit patients and reduce dropout rates.

In fact, he noted, enrollment in one of his current virtual studies, which is tracking people with a genetic tendency for Parkinson’s, actually increased last spring. “While most clinical studies were halted or delayed, our epidemic accelerated in the middle,” he said.

Changes in virtual trials may help diversify clinical research, encouraging low-income and rural patients to enroll, Drs. Halla Borno, an oncologist at the University of California, San Francisco. The epidemic, she said, “really allows us to step back and reflect the burdens we’ve been bearing on patients for a long time.”

Virtual trial is not a panacea. Researchers must ensure that they are able to fully monitor the health of volunteers without in-person visits, and be conscious of the fact that not all patients have access, or are comfortable with the technology.

And in some cases, scientists still need to demonstrate that remote testing is reliable. While Drs. Arnold is optimistic that in-house cognitive tests can provide a better window into his patients’ everyday functioning, adding that homes are uncontrolled environments. “There may be 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 director of health services research at Cedars-Sinai Health System, often uses Fitbits to monitor distant subjects. But one participant once put an instrument on a dog. Many others sent their Fitbits via Wash. “You suddenly get a lot of steps – thousands and thousands of steps,” he said.

And some treatments may not work just a short distance away. Last January, 61-year-old Clay Coleman Jr., a Chicago resident, enrolled in a clinical trial to treat his peripheral artery disease, which caused severe pain whenever he tried to walk. “It was very hard,” said Mr. Coleman, who doesn’t drive. “My feet are very important to me because that’s how I get around.”

He hoped that the test – which included taking blood pressure medication and participating in a supervised exercise program – could get him back in shape. Three times a week, he traveled to a local gym for a structured treadmill workout with a coach. “It was probably six weeks or more before I came to terms with this virus,” he said.

Suddenly, Jim was out. Instead, Mr. Coleman’s coach called him regularly on the phone and encouraged him to proceed.

Dr. Mary McDermott, A The Northwestern University general intern running the trial is not sure how effective such remote coaching would be. “We cannot assume that remote interventions are going to be the same,” she said. “Or that remote measurements are going to replace everything we’ve done in person.”

Nevertheless, the epidemic has demonstrated that there is room for improvement. The cardiologist at Brigham and Women’s Hospital in Boston, Drs. Deepak Bhatt is part of a team to begin an injected blood thinner test later this year. After the first, in-person medical visit, the appointments will be virtual.

He said, “I am sure that if there were no Kovids, we would have acted in a normal way.” Sometimes, he said, “it is a crisis to provoke change.”

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