A study looking at the landscape of COVID-19 research in Australia shows an impressive rapid response in clinical trials to the pandemic, but researchers say the haste in funding, development and implementation highlight new challenges.
In a study published in the Medical Journal of Australia, University of Sydney researchers looked at clinical trials conducted in Australia focused on the COVID-19 pandemic between 1 January to 16 November 2020. They identified crucial research areas which were overlooked, such as there being no trials on public health communication or community transmission prevention related to COVID-19.
There was a significant emphasis on treatment trials (60 percent, 34 out of 56 COVID-19 focused trials).
The researchers state extensive media coverage and public opinion may have misled research prioritization. For instance, there may have been too many uncoordinated hydroxycholorquine trials, randomizing too many patients to non-effective or even potentially harmful treatments.
There was also a concerning lack of collaboration between clinical trials, with 80 percent of trials stating they are not planning to share data.
Researchers are calling for infrastructure to make collaboration easier for Australian researchers, such as funding for data-sharing efforts and minimum standards for collaboration and data sharing.
“In Australia, the COVID-19 pandemic has led to rapid changes in some processes including fast-tracked funding, ethics approvals, trial registration, and publication,” says lead author Dr. Anna Lene Seidler, a Research Fellow at the University of Sydney’s NHMRC Clinical Trials Center.
“Whilst research scale up has been impressive, some of these trials may not have been sufficiently strategic or collaborative, which may have led to taxpayer-funded research waste.
“Going forward, we need protocols to fast-track procedures in emergency scenarios that balance both rigor and urgency.”
The academics analyzed clinical trials data from 1 January to 16 November 2020, from the Australian New Zealand Clinical Trials Registry and ClinicalTrials.gov, which captures 95 percent of registered trials recruiting in Australia. They found:
- 56 trials addressing COVID-19 directly, of which 34 were treatment trials.
- 12 trials addressing the indirect effects of the pandemic.
- 40 trials (71 percent) had no commercial sponsor and were funded by government or not-for-profit sources.
- Only four were completed (7 percent), with the remainder recruiting (n = 26, 46 percent), not yet recruiting (n = 24, 43 percent), or withdrawn (n = 2, 4 percent).
- Only seven trials (12 percent) included populations at high risk of poor outcomes from COVID-19 such as people with comorbidities.
Lack of collaboration concerning
The researchers also found that most treatment trials were too small to detect reliably if a treatment could prevent COVID-19 deaths.
“The median target sample size was small (150), meaning that, individually, trials were likely underpowered to detect differences in clinically important outcomes,” wrote Dr. Seidler and colleagues.
“None of the identified treatment trials are sufficiently powered to detect typical differences in mortality; and with low case numbers in Australia, it seems unlikely that a single trial could obtain such large sample sizes.”
Trial organizers seem reluctant to share data, despite several high-profile calls for collaboration and data sharing across studies, a development the researchers described as “concerning.”
“These calls seem to pass largely unheard among triallists in Australia, with 80 percent (41 trials) indicating they are not planning to share data.
“Frequently mentioned barriers to data sharing include a lack of understanding of the relevance, lack of resources to prepare data, insufficient academic recognition, and concerns about participant privacy, ethics approval and data misuse.”
Senior author Professor Angela Webster from the University of Sydney’s NHMRC Clinical Trials Center said: “It would have been better if researchers had worked together and combined their expertise and resources to conduct larger trials, or a suite of similar trials for which results could be combined upon completion for more impactful research evidence.”
Improvement needed for research impact
Professor Angela Webster and co-authors said: “Too little has happened in creating infrastructure and funding for rapid collaboration, advanced adaptive methodologies and data sharing.
“In future, with adequate funding for technological innovation, clinical trial registries may play a key role in automatically connecting similar trials and facilitating collaboration.
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