HUNTER medical research projects requiring direct contact have been stopped, stalled, or modified due to the COVID-19 pandemic, delaying results that could change, or save, lives.
Hunter researchers say the pandemic has had a significant impact on clinical trials in the region, following a "clear downturn" in the number of people participating in medical trials since the virus reached the region in March.
Prior to the pandemic, there were roughly 400 medical trials approved or underway across the Hunter New England region. But many have "ground to a halt" as limiting direct contact between patients and researchers became necessary, Hunter Medical Research Institute director, Tom Walley, said.
"The importance of clinical trials is absolutely paramount to developing new therapies," he said.
"No doubt a lot of trials are going to run slowly, it may be that some could collapse completely.
"A lot of the trials that involve direct patient contact have had to be stalled or stopped or modified, or they never got started in the first place.
"Some trials are starting to pick up now, because a lot of our innovative researchers have been trying to find ways to do the trials without patient contact. Research is a key part of health care, we can't go forward without it."
Professor Walley said there was a risk that "patient harm" would not just erupt from the direct threat of COVID-19, but also from being unable to get the care required because everything had been "clocked back" or focused on the virus globally.
The pandemic had been a great opportunity to explore telehealth options in research, but while it was effective and efficient for many trials, others simply needed to be done face-to-face.
"There's no way around that in the current situation," he said. "We are trying to work as innovatively as we can to get around this, but there is a limit to how much we can do."
Professor Walley said funding would be a key concern for the foreseeable future.
"If you have three years of funding for a trial and you can't recruit for six-to-12 months, the whole thing may have to collapse unless more funding can be found," he said. "The state and federal funding bodies are aware of this and very sympathetic to it, and they are considering how they can put resources in place to maintain those.
"In some cases they have already invested hundreds of thousands of dollars in the research.
"A lot of the trials that involve direct patient contact have had to be stalled or stopped or modified, or they never got started in the first place... Research is a key part of health care, we can't go forward without it."Professor Tom Walley, director of Hunter Medical Research Institute
"Likewise, some of the trials here at HMRI are supported by philanthropic funding, and we are trying to support researchers the best we can. But it is going to be a struggle, there is no doubt about it. In terms of getting the results that patient's need, that is undoubtedly going to be delayed."
Professor Walley said governments had spent a lot of money on the challenge presented by COVID, which inevitably meant there was less money for other things.
"People are seeing research as a way out of COVID, and that has raised an appreciation of the importance of medical and health research, which is good," he said.
"But in practical terms, many researchers may have insecure contracts, and they are watching the clock ticking down on those projects at a time when they can't deliver the research, which is how they get their next contract.
"So that's a cause of justifiable anxiety, and from the patient point of view - the kind of research that patient's need - the results are going to be slow. Slower than we'd like, and in some cases, may not come at all because the money has been diverted elsewhere into things that are more immediate priorities."
He said the impact of COVID-19 on research was slowing, or halting, advances in medicine.
"There has been quite a big reduction in the number of people going on to clinical trials," he said. "Most of the time patients are happy to be involved, but because of a variety of restrictions in movement around sites, reductions in staff, or limiting visits, there has been a reduction of patients going on to the trials - which means we won't get the answers for a longer period of time.
"If the lockdowns continue, some trials may not get the answers they'd hoped for because they just don't have the numbers."
Jemima Dzator, a registered pharmacist and PhD candidate at the University of Newcastle, said she had initially received a lot of interest in her clinical trial exploring whether a substance found in grapes and nuts could be an effective treatment for debilitating menstrual migraines.
"But then when the COVID-19 cases started increasing earlier this year and we went into lockdown, our ability to see participants was affected and we had to suspend the trial for about three months," she said. "Now, we have only seen about 10 per cent of the participants we need for the study.
"It is disappointing it has dampened our ability to see volunteers in the clinic."
They had asked for an ethics amendment to allow more participants to do the trial remotely, but that would mean sacrificing some insightful data for a potentially novel migraine treatment.
"Things like measuring blood flow in the brain, or obtaining blood samples to measure inflammation, you can't do that remotely," she said. "We are missing out on quite a lot of data that would have been helpful.
"In terms of my migraine research, there will be more people experiencing migraine due to stress - so the issue is still there, but the finding of a new treatment is delayed at the moment."
To find out more about the migraine trial, call the Clinical Nutrition Research Centre on (02) 4921 8616 or email firstname.lastname@example.org.
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