When the pandemic hit last year, clinical trials were affected. Universities closed and hospitals focused on fighting the new disease. Many studies that required repeated personal visits to volunteers have been delayed or canceled.
However, some scientists found creative ways to continue their research even when the personal interaction was inherently risky. They sent medicines Tests conducted via video chat and asked patients to monitor their own vital signs at home.
Many scientists say this shift towards virtual studies is long overdue. If these practices persist, they could make clinical trials cheaper, more efficient and fairer, and provide cutting-edge research opportunities to people who otherwise would not have the time or resources to use them.
“We’ve found that we can do things differently and I don’t think we’ll be going back to the way we used to know,” said Dr. Mustafa Khasraw, a Medical oncologist and clinical trial specialist at Duke University.
According to one analysis, nearly 6,000 studies have been registered on ClinicalTrials.gov stopped between January 1 and May 31, roughly twice as many as in times without a pandemic.
For example, at Johns Hopkins University, researchers delayed their study of how adults ages 65 to 80 metabolized tenofovir, a drug used to prevent and treat HIV
“The idea of recruiting older people who we know are at particular risk – recruiting them to answer a fundamental question that doesn’t immediately change care or affect their health – just didn’t seem like it what we should do, “said Dr. Namandje Bumpus, the pharmacologist leading the study, which is on hold.
In Flint, Michigan, researchers had to stop enrolling emergency patients in a hypertension study. Other volunteers dropped out or were difficult to contact.
“Their phone service is down, or they have very different schedules, or they are harder to reach because they care about someone,” said Dr. Lesli Skolarus, a stroke neurologist at the University of Michigan who is leading the study.
Dr. Skolarus and her colleagues have continued the process, albeit with a few changes. Most importantly, they canceled their personal follow-up exams and instead asked participants to take blood pressure cuffs with them and send photos of the readings via SMS.
Other research teams made similar adjustments. Neurologists at Massachusetts General Hospital in Boston revised 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 now receive their medication in the mail, take cognitive assessments via video conferencing, play brain games on their computers, and conduct daily surveys at home.
“In essence, it is now an entirely virtual study,” said Dr. Steven Arnold, the neurologist who led the study.
Apr. 18, 2021, 10:01 p.m. ET
Even when scientists can’t eliminate personal visits, they find ways to reduce them. When Lorraine Wilner, a 78-year-old retiree with metastatic breast cancer, first started a clinical trial at Duke University last summer, she had to take a three-hour drive to the Durham, NC campus every four weeks for blood tests and occasionally other tests. She said she always left 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 of the people don’t wear a mask,” she said.
She can now have her blood drawn at a laboratory near her home in Lancaster, SC. The researchers then review the results with her over a video call. She still has to drive to Duke for regular scans, but the reduced travel has been a huge relief. “It makes it a lot more convenient,” she said.
Distance learning is likely to continue in a post-pandemic period, researchers say. Reducing face-to-face visits could make patient recruitment easier and lower dropout rates, which could lead to faster and cheaper clinical trials, said Dr. Ray Dorsey, a neurologist at the University of Rochester who has done remote research for years.
In fact, its inclusion in one of his recent virtual studies tracking people with a genetic predisposition to Parkinson’s actually spike this past spring. “While most clinical trials were suspended or delayed, ours accelerated amid the pandemic,” he said.
Moving to virtual trials could also help diversify clinical research and encourage low-income and rural patients to enroll, said Dr. Hala Borno, oncologist at the University of California at San Francisco. The pandemic, she said, “really allows us to step back and reflect on the burdens we have placed on patients for a long time.”
Virtual trials are not a panacea. Researchers need to ensure that they can thoroughly monitor the volunteer’s health without personal visits and be aware of the fact that not all patients have access to or are familiar with technology.
In some cases, scientists have yet to demonstrate that remote testing is reliable. While Dr. Arnold is optimistic that home cognitive testing could provide a better window into the day-to-day functioning of his patients, he noted that environments at home are uncontrolled. “Maybe a cat is crawling on you or grandchildren in the next room,” he said.
There is also the unpredictable nature of human behavior. Dr. Brennan Spiegel, gastroenterologist and head of health research at Cedars-Sinai Health System, often uses Fitbits to monitor subjects remotely. But one participant once put the device on a dog. A few others sent their Fitbits through the laundry. “You suddenly get a lot of steps – thousands and thousands of steps,” he said.
And some treatments may not work as well remotely. Last January, Clay Coleman Jr., a 61-year-old Chicago resident, took part in a clinical trial to treat his peripheral artery disease, which caused severe pain with every attempt to walk. “It was very difficult,” said Mr. Coleman, who is not driving. “My legs are very important to me because this is how I get around.”
He hoped the study of 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 an instructor. “I was there maybe six weeks before this virus thing came up,” he said.
Suddenly the gym was out. Instead, Mr. Coleman’s trainer called him regularly and encouraged him to keep moving.
Dr. Mary McDermott, a The general internist at Northwestern University running the study isn’t sure how effective this type of remote coaching will be. “We cannot assume that remote intervention will be the same,” she said. “Or that remote measurements replace everything we have personally done.”
Still, the pandemic has shown that there is room for reform. Dr. Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston, is part of a team that will start a study of an injectable blood thinner later this year. After the first personal doctor’s visit, the appointments will be virtual.
“I’m pretty sure if Covid hadn’t occurred we would have done things the usual way,” he said. Sometimes he added, “It takes a crisis to provoke change.”