When the pandemic took place last year, clinical trials took a hit. Universities have closed and hospitals have turned their attention to fighting the new disease. Many studies that require repeated, personal visits with volunteers have been delayed or deleted.
But some scientists have found creative ways to continue their research, even if the interaction was inherently dangerous. They posted medicine, exams conducted on video chat and asked patients to monitor their own vital at home.
Many scientists believe that this move to virtual studies is no longer necessary. If these practices continue, it can make clinical trials cheaper, more effective and more equitable, and offer you the latest research opportunities to people who otherwise would not have the time or resources to utilize them.
“We have discovered that we can do things differently, and I do not think we will go back to life as we knew it before,” said Dr. Mustafa Khasraw,’n medical oncologist and specialist in clinical trials at Duke University.
According to one analysis, nearly 6,000 trials were registered on ClinicalTrials.gov stopped between January 1 and May 31, about twice as much compared to non-pandemic times.
At Johns Hopkins University, for example, researchers delayed their investigation into how adults aged 65 to 80 metabolized tenofovir, a drug used to prevent and treat HIV.
“The idea of recruiting older people we know is particularly vulnerable – recruiting them to answer a fundamental question that is not going to change care immediately or affect their health. It seemed like that was not what we were getting. should not do, “said dr. Namandje Bumpus said. , the pharmacologist who led the study, who is still on guard.
In Flint, Michigan, researchers had to stop enrolling emergency patients for a hypertension trial. Other volunteers discontinued the study or became difficult to reach.
“Their telephone service has declined, or they have very different schedules, or it’s harder to reach because they are looking after someone,” said Dr. Lesli Skolarus, a stroke neurologist at the University of Michigan who is leading the study, said.
Dr Skolarus and her colleagues kept the trial going, albeit with some modifications. Most importantly, they personally deleted their follow-up visits, but asked participants to take blood pressure cuffs with them and send photos of the readings via SMS.
Other research teams have made similar adjustments. Neurologists at the Massachusetts General Hospital in Boston have refurbished a pilot study of methylphenidate, the active ingredient in Ritalin, in the elderly with mild dementia or cognitive impairment. Instead of going to the hospital every two weeks, study participants now receive their medication by mail, take cognitive assessment during a video conference, play brain games on their computers, and do daily recordings at home.
“In essence, it’s now a total virtual trial,” said Dr. Steven Arnold, the neurologist who led the trial, said.
Even if scientists cannot eliminate personal visits, they find ways to reduce them. When Lorraine Wilner, a 78-year-old retiree with metastatic breast cancer, began a clinical trial at Duke University for the first time last summer, she had to drive to the Durham, NC campus for three hours every four weeks for blood work. and occasionally other tests. She said she would always leave with a full petrol tank, ‘so I do not have to stop at a petrol station or touch things or go to places where half the people do not have a mask’, she said. she said.
But she can now have her blood drawn in a lab near her home in Lancaster, SC. Researchers reviewed the results with her over a video call. She still has to drive to Duke for periodic scans, but the reduced travel was a big relief. “It makes it a lot more convenient,” she said.
Remote trials are likely to continue into a post-pandemic era, researchers say. Reducing personal visits can facilitate patient engagement and reduce drop-out rates, leading to faster, cheaper clinical trials, Drs. Ray Dorsey, a neurologist at the University of Rochester who has been doing distance research for years.
In fact, he noted that enrollment in one of his current virtual studies, which locates people with a genetic predisposition to Parkinson’s, actually increased last year. “While most clinical trials have been interrupted or delayed, ours has accelerated amid the pandemic,” he said.
The shift to virtual trials could also help diversify clinical research, encouraging more low-income and rural patients to enroll, Drs. Hala Borno, an oncologist at the University of California, San Francisco, said.. The pandemic, she said, “really allows us to step back and reflect on the burdens we have placed on patients for a very long time.”
Virtual trials are not a panacea. Researchers will need to ensure that they can closely monitor the health of volunteers without personal visits, and should note that not all patients have access to, or are comfortable with, technology.
And in some cases, scientists still have to show that remote testing is reliable. Dr. Arnold is optimistic that cognitive testing in the home can provide a better window into the day-to-day functioning of his patients, but he notes that homes are uncontrolled environments. “Maybe a cat is 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 the Cedars-Sinai Health System, regularly uses Fitbits to remotely monitor subjects. But one participant put the device on a dog once. Several others sent their Fitbits through the wash. “You suddenly get a lot of steps – thousands and thousands of steps,” he said.
And some treatments may just not work as well remotely. 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 when he tried to walk. “It was very difficult,” he said. Coleman, who does not drive. “My legs are very important to me, because that’s how I get around.”
He hoped that the trial – which involves the use of blood pressure medication and participation in an exercise program under supervision – could get him back on track. Three times a week, he traveled to a local gym for a structured treadmill workout with a trainer. “I was there for maybe six weeks or so before this virus arrived,” he said.
Suddenly the gym was outside. Instead, Mr. Coleman’s coach regularly called him and encouraged him to keep moving.
Dr. Mary McDermott, a general intern at Northwestern University conducting the trial is not sure how effective this type of distance coaching will be. “We can not accept that remote interventions will be the same,” she said. “Or that distance measurements will replace everything we did personally.”
The pandemic nevertheless showed 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 begin a trial later this year with an injectable blood thinner. After the first, personal medical visit, appointments will be virtual.
“I’m pretty sure if Covid hadn’t happened, we would have done things the usual way,” he said. Sometimes, he added, “it takes a crisis to provoke change.”