Australia has wasted valuable resources and time by funding fragmented pieces of research into COVID-19, rather than taking a strategic, national approach to establishing clinical trials of potential treatments, leading researchers claim.
The Federal Department of Health has defended its grant-based funding model for COVID-19 research, despite criticism from some respected respiratory and pharmacology researchers who say a national clinical trials platform is needed to fast-track trials of existing medications and ‘buy time’ while antiviral drugs and vaccines are developed.
Respiratory physician and researcher Conjoint Professor Peter Wark said Australia had “taken its eye of the ball” on COVID-19 research, with many researchers spending their time writing applications for competitive grants, rather than working collaboratively on trials.
In June, the Federal Government announced $66 million funding for a range of COVID-19 research, with the funding spread across more than 16 research groups.
Professor Wark, from the Centre for Healthy Lungs, Hunter Medical Research Institute, Newcastle, said a national clinical trial framework for COVID-19 would be more effective than funding separate research projects.
“Australia would have been further ahead in enrolling patients in clinical trials of treatments if they had got people together in a collaborative way and funded a clinical trial platform across Australia,” he said, adding that the UK had adopted such a system.
“I think we are missing the boat. I think we should cut out the nonsense of writing grants and strategically get on with it.”
Business as usual approach won’t work
Professor Guy Marks, Professor of Respiratory Medicine at UNSW, Sydney, said because COVID-19 was a novel disease, the “business as usual” approach of funding research to fill knowledge gaps incrementally was not the best approach.
“Really, a big picture question needs to be solved. We ultimately are going to need large scale clinical trials of interventions – initially repurposed drugs and eventually new drugs,” he said.
He said a multidisciplinary expert panel should be established to decide on intervention priorities, and to avoid multiple small trials competing for the same pool of participants.
In an unpublished document outlining their envisaged COVID-19 research model, Professor Marks and Professor Jennifer Martin, chair of clinical pharmacology at University of Newcastle and a general physician at John Hunter Hospital, wrote:
“Already significant resources have been effectively wasted by the NHMRC and State and Commonwealth Health Departments funding toxic and ineffective trials and off-label use, using drugs such as hydroxychloroquine and lopinavir/ritonavir, which an expert panel drawn from a variety of clinical disciplines, would have prevented. We still have no options for treating patients, and are in effect, treating COVID with the same treatments as we treated influenza pandemic with over 100 years ago.”
The WHO last month discontinued its trials of both hydroxychloroquine and lopinavir/ritonavir for COVID-19, after early findings showed they conferred no benefits.
Single national approach needed
Professor Martin also joined with Emeritus Professor Richard Head, a pharmacologist from the University of South Australia, to urge a research focus on ‘treating the host’ – or treating the patient with COVID-19 rather than the virus itself.
Clinically evaluating existing drugs could mitigate the life-threatening inflammatory respiratory processes that are a key factor in COVID-19 and could buy time for the concurrent development of antiviral drugs and vaccines, they said.
Professors Martin and Head outlined their concerns about COVID-19 research in a submission to the Senate Inquiry into Australia’s response to COVID-19
“As seasoned investigators, we saw fragmentation. Fragmentation of a national focus, fragmentation of strategy, fragmentation of effort and fragmentation [of] resources,” they wrote of the current approach.
They said a single national panel was needed to identify a “therapeutic armamentarium” of the top five to 10 drugs on which Australia could focus pandemic research.
Professor Head told the limbic “it was never too late” to take such an approach.
“I think the message really is that we can evolve to another model or modify the existing one,” he said.
A spokeswoman for the Federal Department of Health said experts from across Australia provided advice on COVID-19 research priorities to a Research Roundtable in February. Advice was also being provided by the National COVID-19 Health and Research Advisory Committee established in April, the Rapid Research Information Forum and the Medical Research Future Fund expert advisory panels, she said.
The spokeswoman said the National COVID-19 Clinical Evidence Taskforce was also able to provide advice on evidence gaps, and organisations such as the Australian Clinical Trials Alliance promoted clinical trial networks and registries that generated evidence.
“Where necessary and appropriate research has been direct sourced from institutions with a proven track record. However competitive grant opportunities assessed through peer-reviewed processes are generally preferred to ensure the integrity of the research design, quality and safety for patients, and best return on Government investment. These processes have been expedited for time-critical COVID-19 research,” she said.