Too many COVID-19 clinical trials state a Canadian-led research group as their findings were recently published in The Lancet. A frantic rush to ramp up research, while well-intentioned, led to a complicated configuration of clinical research trials lacking cohesion and actual oversight concerning aspects of this mysterious new disease called COVID-19. Of the 1,900+ clinical trials ongoing, these researchers believe that only a dozen or so will offer society truly reliable knowledge. This unfortunately represents a huge waste of money, talent, and resources. The corresponding researchers suggest that absolutely no leadership stepped up to oversee Canada’s clinical trials. Perhaps with Operation Warp Speed the U.S. had more oversight and governance than other places?
With the onset of COVID-19 in the U.S. and beyond, the federal government, academia, non-profit research centers, and industry full-throttle accelerated multiple and myriad research trials faster than at any time in history. This speed has been celebrated by the industry, by policymakers, by government, and regulators. But according to corresponding author Edward J. Mills with McMaster University, Ontario, Canada, the “inadequate details on the trial and only superficial scrutiny by the public and scientific decision makers” leads to “disastrous effects on clinical trial funding, permission, recruitment, and interpretation.” Professor Mills should be intimately familiar with this challenge as he and colleagues run several international clinical trials addressing COVID-19 in one way or another.
Record Number of Trials
As it turns out, COVID-19 has triggered more clinical trials than any other disease in the history of humanity. What is the result? According to the authors, hurried and jumbled planning has led to confusion, funding challenges, and ultimately a whole lot of clinical trials that won’t be completed.
Disjointed Confusion in Regards to COVID-19
The SARS-CoV-2 infection leading to COVID-19 manifests in five distinct stages for therapeutic intervention, including 1) pre-exposure prophylaxis, 2) post-exposure prophylaxis, 3) outpatient treatment, 4) hospital admission, and 5) late-stage critical care.
The challenge, reports Mills and colleagues, is that because there has been a complete lack of command and control, even with initiatives such as Operation Warp Speed and ACTIV, the findings applied to a trial addressing one COVID-19 stage is actually applied to a different stage of the disease.
Interview with Yahoo Canada
Professor Mills spoke with Yahoo Canada about the findings telling the online media’s Elianna Lev, “Most trials that get reported, they have occurred within the hospitalization population and then the media and social media reports as if they’re applicable to all stages of the disease.” He continued for Ms. Lev, “It’s having disastrous effects on people trying to do clinical trials on other aspects of the disease.”
The media’s job is to report the news. It’s the medical and research profession, rather to provide the framework, the context, and the parameters for how a study should be reported. Often media operations don’t retain scientists just to decipher clinical trial results. Rather it’s up to the medical and scientific community to conduct research and report on the results, sharing how and where the findings fit into the broader understanding for the collective response against COVID-19.
Professor Mills told Yahoo Canada, “You have an awful lot of commentators and people giving advice on COVID, but the reality is there’s very little cohesion in terms of opinion on what to do with the disease.”
The Example: Hydroxychloroquine
Professor Mills tells Yahoo Canada about a prime example: Hydroxychloroquine. The media’s emphasis on U.S. President Donald Trump and Brazilian President Jair Bolsonaro embrace the malaria drug politicized the entire research process. Ms. Lev of Yahoo Canada notes that although there was “compelling evidence for the drug, it was focused on the prevention stage or during the early onset of COVID-19. When studies looked at the drug’s effect on hospitalized patients, it didn’t prove successful. As a result, many trials got canceled.” Professor Mills chimed in, “We still don’t know whether hydroxychloroquine works for the condition it was initially purported for, which was prevention or early treatment.”
Pandemic Lockdowns Disrupt Scientific Discussions
Interestingly, the Yahoo Canada piece emphasizes that the lockdowns and sequestering resulting from the pandemic have led to a situation where people are more isolated, including scientists. Typically, many scientists and investigators would converge on conferences or grand rounds to discuss, debate, and ponder the disease’s implications and the subsequent research.
What about the USA?
The Trump Administration organized Operation Warp Speed (OWS), an unprecedented national effort to develop, organize, and coordinate federally funded research. Actual federally funded trials are led by the National Institutes of Health’s (NIH) ACTIV. Although the OWS initiative came a bit late, at least it’s evidence of government scientists taking the initiative to organize programmatic research responses to COVID-19. Several critiques have emerged, from the lack of transparency to what some have suggested could be wasteful spending. But regardless of position, there is a centralized organizing body in the U.S. accountable for how federal dollars are allocated to COVID-19 clinical trials.
Edward J. Mills, Professor, Advisor Bill & Melinda Gates Foundation