Need to know:
- Despite the pandemic, Australia’s new non-Covid-19 interventional drug trial numbers exceeded prepandemic levels by August 2020, with a positive trajectory maintained in 2021.
- The increase in trial activity saw a rise in demand for clinical research organisations (CRO). In fact, more than one in four trials in Australia were CRO-led in recent years, compared to one in every 10 trials in 2010.
- But there are unique challenges in running trials in the country, such as trials having to compete for the same patients, and workforce shortages due to international border closure.
- Australia’s clinical trial activity was mostly driven by smaller sponsors rather than big pharma. Trials in solid tumours and bacterial infection saw a notable increase in recent years.
- While Omicron has led to another surge in the country, local border closures among states allow nonaffected regions to still run as normal. Clinical trial sites are upgrading to decentralised approaches based on learnings from local and overseas experience.
It was a good run: in December 2021, almost two years into the global pandemic, Australia reported more than 5,000 new daily Covid-19 cases for the first time ever. The country was able to keep cases low for so long due to strict border controls and state-wide lockdowns. While the long-term merits of Australia’s so called “zero-Covid” strategy continue to be debated, it is clear from our analysis of clinical drug trial activity that this approach triggered a boost to the nation’s clinical research sector.
With Covid-19 overwhelming health services throughout Europe and North America during the summer of 2020, Australia was viewed as an attractive alternative in running clinical trials as pharmaceutical companies explored options that would allow them to restart or initiate clinical trials, or at the very least delay pandemic-related disruption.
In fact, the number of new non-Covid-19 interventional drug trials in Australia recovered to exceed prepandemic levels by August 2020 and then continued to rise. In 2021, 27% more trials began in Australia compared with 2019, as revealed by an analysis of clinical trials protocol data collected by GlobalData. In comparison, the UK, Germany and Spain all saw activity fall from 2019 to 2021.
Bigger CRO clinical trial footprint in Australia
Australia’s clinical research sector was already expanding prior to the pandemic. That growth coincided with the rise of several Australian CROs and a more prominent role for local CROs in the global industry. As a testament to this growth: more than one in four single-country trials in Australia were CRO-led in recent years, compared to less than one in every 10 trials in 2010.
Collectively, the eight CROs leading the most single-country trials in Australia initiated more than 140 trials during 2021. Those same organisations led an average of under 40 trials each year between 2010 and 2016.
Over the past decade, Australia has developed a reputation as a top location for conducting early-phase clinical trials. And the increase in demand for the country’s CROs has been strongest for Phase I trials. Between 2010 and 2014, just 16% of CRO-led interventional drug trials in Australia were Phase I but by 2021 this figure had increased to 40%. Six of the country’s eight most active CROs specialise in early-phase trials, conducting a total of around 80 Phase I trials and just four Phase II trials in 2021.
Different trial challenges in Australia
There are unique challenges faced by local CROs in running trials from a country generally considered insulated from a pandemic. Linear Clinical Research CEO Jayden Rogers says: “demand for clinical trials in Australia is at all-time highs, with demand far exceeding capacity to accommodate.” Volunteer recruitment has been challenging due to the volume of trials running per site, he adds.
Also, in terms of beds and labour force capacity, to serve trial demand has been constrained, Rogers adds. Demand is such that Linear is undergoing expansion to triple bed capacity by the end of 2022, he notes. Labour force is impacted due to closed borders and low levels of migration, with many professionals hailing from overseas, he explains.
And Covid-19 experience can vary among the Australian states, with local authorities shutting borders to prevent transmission among them, says Dr Simone Strasser, clinical associate professor at the University of Sydney . In states like New South Wales and Victoria, enrolment was significantly affected due to local surges, she added.
Smaller sponsors leading clinical trial activity
Australia has experienced growth in clinical trial activity during the past decade, this is despite failing to attract large global pharmaceutical companies. None of the 10 most active commercial sponsors have staged more than five single-country trials per year in Australia since 2017 (Novartis has conducted the most at just over four per year).
Instead, the expansion of Australia’s clinical research sector has primarily been driven by small commercial sponsors. Between 2010 and 2014, small companies sponsored 46% of all non-Covid-19 single-country commercial interventional drug trials in Australia. By 2021, that figure had soared to 77%. Despite the pandemic, more than 200 commercial pharmaceutical companies sponsored a clinical trial in Australia for the first time during the past two years, the highest ever rate of new entrants to the country’s clinical research market.
Many of the disease areas where Australia has seen the strongest growth in activity prior to Covid-19 also proved to be the most resilient once the pandemic hit. Australia had seen a tripling of solid tumours trials between the beginning of the decade and 2019. And while other countries saw a reduction in new solid tumour trials during 2020, in Australia they rose again.
It was a similar story for bacterial infections, a disease area where new interventional drug trials have risen in Australia in recent years, while declining in Europe and North America. While trial levels fell by almost 30% in the UK and US during the pandemic, they held steady in Australia.
The one disease area where Australia may have been viewed as not having thrived during the pandemic is in Covid-19. The country's strength in conducting phase I trials may have made Australia an attractive location for early-stage vaccine trials, however, with the country’s Covid-19 case rate being low overall throughout the majority of the past two years, later-stage trials – which are designed based on robust community infection rates – have been harder to execute.
As a result, Australia was often passed over when pharmaceutical companies came to select locations to stage large multicountry Covid-19 studies. While Australia has been chosen as a location for over three in every 10 multicountry trials during 2020 and 2021 in other indications, for Covid-19 trials the rate is less than one in 10.
Australia has also seen less single-country trials researching Covid-19 than other countries with similarly sized clinical research sectors. While Australia and the UK are each the setting for around 4% of all single-country clinical trials, for Covid-19 trials Australia’s share is just 2%.
Will Omicron dampen Australia’s momentum?
With Australia amid a Covid-19 surge due to Omicron, questions swirl if the country can maintain its positive clinical trial trajectory. Strasser says, in her clinical trial site in Sydney, they aim to continue enrolment in cancer trials, however stopped enrolment in trials where there was not a clear benefit to patients and alternative management was available. This affected, for example, nonalcoholic steatohepatitis and hepatitis B trials.
As in other places globally, hospitalisation rates are increasing, with a depleted workforce and many under isolation due to Covid-19 or being a close contact, Strasser adds. Clinical trial staff are often regarded as “nonessential” during a surge and so they are the first to be deployed to testing and vaccination hubs, virtual hospital care, and ward service as community transmissions rise, she says. “We only just got our clinical staff back after Delta, and now are deployed again.”
But this is not to say Australian clinical trial sites are not ready for Covid surges. For example, even in states that have not experienced the full force of Covid-19, sites have begun to implement decentralised approaches. Rogers says Linear was already cloud-based before the pandemic and having full remote monitoring capabilities. These systems held up in 2020 and further refinements allows this system to hold up throughout 2022.
Clarification: The description of the first graph has been clarified as focusing on non-Covid-19 trials, instead of all trials. CRO Nucleus Network acquired CRO Q-Pharm in 2019 but GlobalData continues to identify the companies separately based on clinical trials protocol data, as seen in the first table.