Researchers call for national research strategy for clinical trials in a pandemic

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.”

The authors concluded that “robust reflection” on what has been learned during the COVID-19 pandemic was needed, and made four recommendations:

• Establish a few national platforms in Australia as the principal vehicle for publicly funded trials. Each of these platforms should focus on different disease phases (for example, outpatients, hospitalised/non-critical, intensive care) and include specific patient subgroups (for example, 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.
• Coordinate 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.”