July 21, 2021
Australia should follow the examples of the UK and parts of the US and establish a national, coordinated approach for randomised controlled trials (RCTs) for COVID-19, any future pandemics, and inter-pandemic periods, according to the authors of a Perspective published in the Medical Journal of Australia.
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, wrote that the best of some 3000 randomised control trials (RCT) for COVID-19 had been “well coordinated, pragmatic, publicly supported by government, and funded by national research agencies”.
“In addition, the prior development of national clinical research networks and infrastructure for improved patient care has strengthened pandemic responsiveness,” the authors wrote.
“There has been little central coordination in Australia for the prioritisation and funding of trials. Nor was there a nationally resourced and coordinated trials infrastructure in existence before the COVID-19 pandemic.
“Two critical factors have made it extremely challenging to run therapeutic COVID-19 trials in Australia.
“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.”
Perspective co-author, Associate Professor Steven Tong, a Royal Melbourne Hospital infectious diseases clinician and co-lead of clinical research at the Doherty Institute, and Principal Investigator of the AustralaSian COVID-19 Trial (ASCOT) said the recent outbreaks of COVID-19 across Australia highlight the importance of ongoing infrastructure and preparedness for clinical trials.
“These outbreaks are unpredictable, occur rapidly, and can be widespread. Clinical trials are the best way to offer patients new therapies and to generate the evidence required to determine which of these therapies work,” Associate Professor Tong said.
“While vaccines are critical, we also need improved treatments for those that become infected. Vaccination rates are not optimal, some individuals may not develop as strong and protective an immune response as desired, and vaccination may not be as protective against current or future variants of the virus. The reality is that we will continue to have people getting infected and getting sick with COVID-19 for the foreseeable future.”
Associate Professor 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.
“Furthermore, we recommend that a national pandemic clinical trials prioritisation panel be formed to advise the National Health and Medical Research Council, the Medical Research Future Fund, chief health officers and National Cabinet,” the authors wrote.
“Its key role would be to establish a streamlined approach to funding prioritised trial platforms, consider how to integrate applications for new trials with established trial platforms, and to establish pathways for rapid ethical and governance approval of protocols in the context of a pandemic and advise on any gaps in research.”