Around the Globe

“One-Stop Shop” for Clinical Trial Ethics Approvals Part of Australia’s COVID-19 Response

Richard Day
Japan Self-Medication Industry
University of New South Wales
@osbornidayius
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his past June, Australian Federal Health Minister Greg Hunt announced that the Commonwealth of Australia will join with all our States and Territories to achieve a “one-stop shop” for enhanced clinical trial approvals in Australia. Speaking at the annual State of the Nation Forum, run for the last forty years in our national capital by the highly regarded Committee for Economic Development of Australia (CEDA), Hunt provided an update on the COVID-19 crisis and how Australia has managed so far.

In his remarks about Australia’s research and clinical trial system, he noted: “What we have now is a high degree of international interest, building on what was already a high degree of interest for clinical trials and for research in Australia. Many of the systems in other countries for non-COVID research have had to be put on deep pause and, as a consequence of that, we know already that there’s an interest in rapid movement for phase 1, phase 2, and parts of phase 3 trials to Australia. We are now moving with the states and territories to set up a one-stop-shop for ethics approval. If there is a standard and institutions are included, then that will expedite that investment process. The pharmaceutical companies have said that will bring a more general investment in basic research as well as potential for advanced manufacturing.”

Australian Clinical Trials Alliance Response

This announcement was welcomed by the Chair of the Australian Clinical Trials Alliance (ACTA), John Zalcberg: “In response to COVID-19, we have seen rapid progress and flexibility across the health sector …. and we would like to see that momentum continue. COVID-19 has raised public awareness on the value of an agile health system and highlighted the importance of embedding quality clinical trials into practice. This is a great opportunity to continue to streamline and simplify our ethics and governance systems to ensure that Australia’s world-leading clinical researchers can focus their time and effort on trial conduct, delivering best practice healthcare to improve health outcomes for patients. We understand that the Federal Department of Health, together with the States and Territories, have been working towards a National Front Door platform to connect and modernise the governance and ethics systems across the country, and we support this vision.” Medicines Australia also warmly supported this initiative.

ACTA 2019 Trial of the Year Award

Meanwhile, the 2019 winners of ACTA’s Trial of the Year Award, The ASPirin in Reducing Events in the Elderly (ASPREE) Study which found that taking aspirin did not increase the time healthy people over the age of 70 years remained free of disability or dementia, have received further funding from the US NIH to investigate the long-lasting effects of daily low-dose aspirin in preventing cancer, especially bowel cancer. The principal investigator, John McNeill based at Monash University Public Health and Preventative Health Department, did not rule out that beneficial effects such as delaying cancer could appear after the trial, a question of great relevance to elderly individuals, so participants will continue to be followed. Using a similar approach notable for involvement of primary care practitioners and consumers, the same investigators and multiple Australian Universities have been supported by the National Health and Medical Research Council to examine whether use of statins in elderly individuals prolongs disability-free survival (the StaREE trial), another question arousing much international interest.

Health System Agility, Flexibility, and Capability

COVID-19 has had a profound and rapid impact not only on our society (for example, the dramatic establishment of teleworking) but also on our health system, as is the case globally. Dr. Lesley Russell, Adjunct Associate Professor at the Menzies Centre for Health Policy and a Non-Resident Expert at the United States Studies Centre at the University of Sydney, notes the “extraordinary agility, flexibility, and capability demonstrated by our healthcare system” and hopes that the “dramatic changes in lifestyles and the exposure of the inequality gaps in Australian society will serve as the needed incentive for reforms.” Russell very usefully summarises key themes that have emerged and are worthy of attention, most likely also in many other national healthcare systems. Systematising telehealth, enhancing quality and uptake of electronic medical records, attending to quality and safety in aged care facilities, building national systems of preparedness, attending to reliability of supply chains for medical supplies, improving health literacy, focusing on mental health services, and building on new models of care such as “hospital in the home” have all emerged into the spotlight. There is much hope that these challenges will be taken up with enthusiasm.

And Now for Something Completely Different…

This short article on ocean swimming by Alison Rourke in The Guardian took my fancy and I hope some of yours: Enjoy.