State of nation’s clinical trials amidst shifting landscape: New report

Medical: A new report has revealed that Australia’s clinical trials sector generated $1.6 billion for the economy in 2022. It marks a growth of over 4% since 2019, achieved despite the downturn caused by the COVID-19 pandemic.

Australia is renowned for the quality and global standing of its investigators, advanced research infrastructure and systems, and research and development (R&D) tax incentives, which enhance its cost competitiveness in the global clinical trials ecosystem.

MTPConnect CEO, Stuart Dignam, highlighted the significance of the report, noting its timing with Australia’s trade mission to the BIO International Convention in San Diego, where the nation’s clinical trials expertise was showcased.

“Clinical trials are a critical step in the R&D pipeline for new treatments and as well as ensuring Australian patients receive the best, safest and most effective treatments, these new figures show clinical trials are more valuable for the economy than ever before,” Dignam said.

He added, “It underscores our hard-earned global reputation as a ‘go to’ destination to conduct clinical trials. While the figures show value has increased, there are signs of stagnation in other key metrics.”

The Australian clinical trials sector employed 7,700 people in 2022, slightly down from 8,000 in 2019. Participation by Australians in trials also declined from 95,000 to about 90,000, while the number of initiated trials dropped from 1,880 to 1,850 during the same period.

“There’s no doubt COVID-19 restrictions blunted growth, with significant falls in key metrics seen in 2020. And while there was a robust rebound in 2021, demonstrating the life science sector’s resilience, we’ve not been able to maintain some of those post-COVID gains into 2022,” Dignam explained. “The figures show that we can’t take success for granted and need to keep innovating and investing in order to stay competitive with other international markets like Singapore, the US, and South Korea.”

Industry-sponsored trials have demonstrated more resilience compared to non-industry-sponsored trials during the COVID-19 period, growing by 4.3% per annum from 2015 to 2022. Non-industry-sponsored trials grew at a slower rate of 3.0% per annum over the same period. A significant portion of industry-sponsored trials are funded by multinational companies, with only 9% of industry drug trial sponsors headquartered in Australia. This foreign investment makes a substantial contribution to patients and the broader economy in Australia.

“BeiGene’s leadership identified Australia as a country with strong commitment to clinical trials and the capabilities to successfully conduct complex and critical first-in-human studies,” said Dr Arthur Alston, Head of Medical Affairs, APAC at BeiGene.

Adam Roach, VP and Head of APAC at BeiGene, added “On average in Australia, the first patient into a clinical trial [after approvals] is about three months, whereas in the US or the EU, it’s six to nine months – it’s efficient.”

Recent government funding commitments for the National One Stop Shop, which offers streamlined cross-state ethics and governance approvals, have been welcomed by many stakeholders. These reforms were developed through extensive consultations involving over 1,400 stakeholders throughout 2021-22.

“This presents an opportunity for Australia to leverage its reputation for excellence in early phase trials to become more competitive in attracting late-phase trials and deliver more life-saving innovations to Australian patients,” Dignam stated.

Oncology remains the most frequently studied therapeutic area in Australian clinical trials. The fastest-growing area is neurology, which has expanded at 8% per annum since 2015. With an aging global population and an increased burden of dementia, strokes, and other neurological diseases in people over 65, this growth reflects the urgent need to address these conditions.

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