COVID-19 Pandemic Causing Delays In Local Medical Research
While COVID-19 research has been fast-tracked over the past few months, studies involving other diseases were put on hold.
When COVID-19 cases were first rising in March, hospitals began implementing tight restrictions to limit patients and visitors. University Hospitals researcher Dr. Alan Lerner said he and other staff were in a flurry of anxious Zoom meetings.
“There was a mass move made," he said. "It all happened very quickly.”
Lerner leads several clinical trials for Alzheimer’s research at UH. Within a few days, he said, all of his studies were put on pause.
“We just stopped. Just like that. Everything came to a halt because it wasn’t safe to bring people into offices," he said.
Lerner said researchers postponed observational studies first. Then, they followed suit with drug trials.
The decisions to stop the studies were an effort to reduce the spread of COVID-19 by keeping people out of the hospital. Lerner said it is never ideal to suspend research, but both participants and regulatory bodies were on board.
“People understood," he said. "I mean we’re talking about Alzheimer’s disease, so we’re talking about older people, and those are the people at the highest risk.”
Lerner’s trials were not the only ones affected. About half of UH's clinical trials were temporarily halted or modified due to the pandemic, said Vice President of Research Dr. Grace McComsey. She said some researchers, such as those working on HIV research, were pulled from their studies to work on pandemic-related trials instead.
“Our HIV community is really not happy at all," McComsey said. "They’re feeling that HIV research is being put on the back burner just because all the infectious disease people are busy with COVID.”
Studies were halted at the Cleveland Clinic’s Lerner Research Institute as well. Chair Dr. Serpil Erzurum said while most trials have now resumed, the few months in which they were halted still made an impact.
“It did affect us; things did slow down," she said. "Routine visits for research were converted as best as possible to virtual, or paused. But any slowdown in research has consequences.”
This is an even bigger problem in areas across the country that were hit harder by COVID-19, she said.
“There are universities, research organizations out there that completely shut down - and now, can you imagine reopening?" Erzurum said. "I mean, I don’t think we’re going to know the true impact of this on all research for at least another year.”
Local institutions were able to implement virtual techniques to keep essential research going. Both Erzurum and McComsey said these measures have been incorporated in reopened trials, as well.
For example, medication is shipped to trial participants, who then administer them themselves. Patients also connect virtually with researchers to self-report symptoms. McComsey said she thinks these virtual techniques could make it easier for people to participate and enroll in studies in the future.
“I think this will end up helping research," she said. "More people will say 'yes – if all I have to come is four times during the whole year, it’s way different than telling me, ‘come once a week,’ so it may help us enroll more patients and keep patients, retain patients."
Virtual research measures aren’t ideal for every trial, said Lerner, the UH researcher. He said there are barriers to assessing his participants via telehealth.
“What percentage of 80 year olds own smartphones? How many of them would feel comfortable doing Zoom?” he said.
Lerner said memory testing is a key part of his dementia trials. There is a concern that taking these tests remotely will lead to flawed data. For example, a family member could help the participant with the answers.
He said his biggest concern overall is the variability of the data.
“A lot of these are very long term studies that have been going on, some of them, for 5 years. The statisticians will weigh in on how to adjust for those different outcomes – because it generates missing data," he said. "You don’t want to ruin the scientific integrity of the study.”
Plus, he said, participants may have dropped out during the trial suspensions, which could also cause long-term statistical implications.
Both McComsey and Erzurum said regulatory agencies such as the National Institutes of Health and the Food and Drug Administration have been working with researchers to make proper amendments to the studies and try to mitigate these validity issues.
They also said it is too early to tell the full impact the pandemic has had on medical research, but for now, most fields of study seem to be back on track. That could change, they said, if there is another surge in COVID-19 cases and labs must shut down again.