FDA expert warns the US could run out of researchers to run coronavirus drug trials
There are more than 70 trials for treatments for coronavirus happening in the US, and the race for a therapeutic leave labs shorthanded of researchers, a Food and Drug Administration (FDA) official has said.
‘Although we may not run out of patients, unfortunately, we may run out of research personnel and time availability to do that in this way of having separate development programs,’ said Dr Janet woodcock during a webinar attended by Business Insider.
In addition to the trials of these 72 potential treatments, she said that there are hundreds more being planned, and nearly another thousand requests for COVID-19 treatment research for the FDA to wade through and approve (or reject), Business Insider reported.
Meanwhile, some of the frontrunners in the race for a treatment are beginning to report results – and it’s not all positive, including damning early reports from hydroxychloroquine trials.
An FDA official warned Thursday that the many ongoing and upcoming trials of coronavirus drugs may deplete a crucial research resource: scientists and healthcare workers to oversee the studies (file)
In the US and around the world, hydroxychloroquine and remdesivir have garnered the most attention.
A combination of two HIV drugs – lopinavir and ritonavir – that was an early favorite for treating coronavirus has yielded disappointing results, but some clinical trials for them are still ongoing.
Other studies are investigating whether everything from convalescent plasma from recovered coronavirus patients to experimental cancer drugs and arthritis medications can combat the virus’s devastating effects.
Biotech research and development were slated to get more than $720 million in funding from the US as of earlier this month, according to USASpending.gov.
But even that investment from the government and the capital Big Pharma companies like Johnson & Johnson, Gilead, and Novartis are pouring into treatment studies won’t on its own fill an essential need in the research: scientists.
Running a clinical trial requires a lot of people – both patients and researchers.
A Veteran Affairs trial of hydroxychloroquine is among the many studies ongoing to investigate potential coronavirus treatments (pictured), but early results recently found that more patients taking the drug had died than had patients given only supportive care (file)
Among the 72 ongoing studies are those investigating the use of plasma from the blood of recovered coronavirus patients to treat those still battling the disease (file)
Remdesivir is one of the most highly-anticipated possible coronavirus treatments being studied by multiple groups across the US. Results thus far are mixed
A clinical trial can be run by one person, but the larger the trial and more closely the involved patients need to be monitored, the more people have to be involved.
For example, a single trial could be run across multiple hospitals in various states, requiring a large team of scientists to oversee patients.
And the most robust, reliable trials are the largest ones. Phase III trials commonly involve thousands of patients.
So far, more than 890,000 Americans have contracted coronavirus, so the patient pool is certainly large enough to recruit from, but not all trials have the same criteria and these patients are spread across the states.
In addition to the 72 trials that the FDA has signed off on, Dr Woodcock said that there were another 211 gearing up to begin testing their drugs, and more than 900 requests and proposals for testing coronavirus drugs have been sent to the agency.
‘That’s a rather overwhelming amount in such a short time,’ said Dr Woodcock.
‘You can see that this is a massive effort.’
But investigating each of these treatments individually could stretch the needed human resources even further.
So Dr Woodcock, who oversees the FDA’s Center for Drug Evaluation and Research, is advocating for an ‘adaptive’ approach to studies.
This model has researchers test several potential treatments as part of one trial protocol, comparing the results of multiple different treatments to a single control group.
It’s already being done in the UK, as well as being applied to at least one National Institutes of Health (NIH) trial that focuses most prominently on remdesivir.
Dr Woodcock also said that the potential shortage of researchers to staff coronavirus treatment trials and general difficulty of finding therapeutics underscores broader issues in how research is conducted in the US.
‘This crisis underlies and points out the need to have better clinical trial infrastructure in place,’ she said in the webinar.
Source: Daily Mail | Health News
