AUSTRALIAN COVID-19 researchers appear to be less willing to share their data than perhaps they should be, say academics from the National Health and Medical Research Council’s Clinical Trials Centre at the University of Sydney.
Dr Anna Lede Seidler and colleagues analysed data from the Australian New Zealand Clinical Trials Registry and ClinicalTrials.gov from 1 January to 16 November 2020.
They found 56 COVID-19 trials, only four of which were completed (7%), with the remainder recruiting (n = 26, 46%), not yet recruiting (n = 24, 43%), or withdrawn (n = 2, 4%). Forty trials (71%) had no commercial sponsor and were funded by government or not-for-profit sources. Only seven trials (12%) included populations at high risk of poor outcomes from COVID-19 such as people with comorbidities.
Data sharing seemed to be low on the list of priorities for COVID-19 researchers, despite several high-profile calls for collaboration and data sharing across studies, a development Seidler and colleagues described as “concerning”.
“These calls seem to pass largely unheard among triallists in Australia, with 80% (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.”
Seidler and colleagues wrote in an MJA Perspective that while the research response to COVID-19 in Australia had been rapid, trials had often been underpowered and lacking in analysis of core outcomes.
“The median target sample size was small (150), meaning that, individually, trials were likely underpowered to detect differences in clinically important outcomes,” they wrote.
“None of the identified treatment trials are sufficiently powered to detect such a difference in mortality; and with low case numbers in Australia, it seems unlikely that a single trial could obtain such large sample sizes.
“We assessed availability of the identified core outcomes of mortality, respiratory failure, multi-organ failure, shortness of breath, and recovery.
“Of the 34 COVID-19 treatment trials in Australia, the proportion assessing each core outcome was low. For instance, only 53% (18 trials) assessed mortality, and 18% (six trials) assessed shortness of breath, whereas 63% (21 trials) assessed respiratory failure. Only one trial included all core outcomes, and ten trials (29%) included none.
“Thus, it will be impossible to synthesise results or make important comparisons for many of the trials,” Seidler and colleagues wrote.
In another MJA Perspective, authors from Perth, Melbourne, Darwin and Newcastle called for national coordination of Australia’s pandemic research.
Associate Professor Asha Bowen, a paediatric infectious diseases specialist at Perth Children’s Hospital, and Program Head of Vaccines and Infectious Diseases at the Telethon Kids Institute, and colleagues, said there had been “little central coordination in Australia for the prioritisation and funding of trials”.
“Two critical factors have made it extremely challenging to run therapeutic COVID-19 trials in Australia,” wrote Bowen and colleagues.
“First, the unpredictability of the pandemic, and the small number of patients in Australia compared with other countries, has made patient recruitment difficult.
“Second, the swift accrual of patients and communication of results in overseas studies has resulted in the need to rapidly change protocols and drop interventions for which equipoise no longer existed.”
Bowen and colleagues concluded that “robust reflection” on what has been learned during the COVID-19 pandemic was needed, and made four recommendations:
- A small number of national platforms in Australia, as the principal vehicle for publicly funded trials. Each of these platforms should focus on different disease phases (eg, outpatients, hospitalised/non-critical, intensive care) and include specific patient subgroups (eg, pregnant women, children, immunocompromised hosts). These platforms should be pandemic prepared, and between pandemics focus on relevant research incorporating researchers at all career phases to strengthen and grow the network.
- Coordination of these platforms through defined coalitions of research groups to facilitate sharing of expertise and infrastructure, thus reducing the duplication of efforts and model collaboration across clinical trials.
- Rapid mobilisation of government funds, either through funding networked coalitions of research groups or competitive calls for consolidated large scale funding to self-identified coalitions (with rapid awarding of funding).
- Encouragement from federal and state chief health officers and health ministers for local site involvement in these platforms and creation of structures for mutually accepted governance approvals.
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