Expediting Clinical Trial Study Start-up in Australia

Australia is widely recognised as a leading location for multi-regional clinical trials (MRCTs) in Asia Pacific due to its excellent health system and streamlined regulatory framework that facilitates rapid start-up of clinical trials, especially in early-stage development.¹ Currently, it ranks as the 7th most preferred location worldwide for registered MRCTs, according to the Korea Clinical Trials Statistic Handbook (2022, KoNECT).

If private, rather than public, research sites are involved, then the start-up time can be further reduced to a best case of 8 weeks. Fast study initiation, however, is not the only factor positioning Australia as a leading destination for MRCTs. 

Clinical Trials in Australia

Clinical trials contribute approximately $1.4 billion to the Australian economy annually, including $650 million in foreign investment. Australia’s reputation in clinical research is bolstered by high-quality infrastructure, an ethnically diverse population, stringent yet efficient regulatory systems, and globally recognised clinicians. Over 8,000 Australians are employed in health and medical research, and more than 60% of research outputs are ranked as “above” or “well above world standard”.³

In addition, Australia offers clinical trials across various biologics sub-sectors, including gene therapies, cell therapies, antibody-based treatments, CAR-T therapies, RNA-based therapies and radiopharmaceuticals.¹

Australian Clinical Trials by State, 2023⁴

Clinical Capabilities and Infrastructure

Australia is internationally renowned for its highly trained clinical workforce and the exceptional quality of data produced by its research teams. The country’s state-of-the-art clinical research facilities are equipped with cutting-edge technology for testing, treatment, and analysis. Australia's medical research is ranked 7th globally, with over 1,200 biotech companies, 55 medical research institutes, and 40 medical research-focused universities.⁵

Government Initiatives Supporting Clinical Trials

The Australian government has implemented several initiatives to enhance the clinical trial environment and attract foreign investment. Key initiatives include:

#1. Health Research for a Future Made in Australia

Announced in May 2024, this package represents a “once in a generation” transformation of health and medical research, with a total investment of $1.89 billion. This includes $1.4 billion in new research via the Medical Research Future Fund (MRFF) and $411 million to support researchers tackling Australia’s biggest health challenges.

#2. National One Stop Shop for Clinical Trials

This initiative, boosted by government funding of 18.8 million, will streamline clinical trial processes by harmonising regulations across Australia. The platform will make it easier for patients, researchers, and industry stakeholders to find, conduct, and participate in clinical trials.

#3. Clinical Trials Activity Initiative

A $750 million initiative over a decade (2024-2034) to support clinical trial activity, particularly in rare diseases, rare cancers, and unmet needs. It also aims to attract investigator-led international trials to Australia.

#4. R&D Tax Incentive (RDTI)

The RDTI helps companies offset the costs of eligible research and development, offering both refundable and non-refundable tax offsets depending on the company’s turnover and R&D expenditure.

#5. mRNA Clinical Trial Enabling Infrastructure Grant

Providing $5 million to organisations to support clinical trials of mRNA-based vaccines and therapeutics.

#6. Biomedical Translation Fund (BTF)

This fund offers venture capital to help biomedical discoveries transition into tangible products, services, and outcomes, ensuring Australia remains competitive in the global health research landscape.

Favorable Regulatory Ecosystem

Australia’s regulatory body, the Therapeutic Goods Administration (TGA), oversees clinical trials involving 'unapproved' therapeutic goods. The two primary pathways for approval are the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.

Clinical trials in Australia must have a local sponsor with a registered legal entity in Australia. An overseas company, person or entity, cannot be the 'local sponsor' of the trial in Australia. The local sponsor must submit the CTN or CTA. The trial sponsor is responsible for the initiation, management and financing of the trial and the associated medico-legal responsibility.¹ The Guideline for Good Clinical Practice and ISO 14155 allows a trial sponsor (client) to delegate any or all of the sponsor's trial-related duties and functions, including safety reporting, to a third party such as a CRO. Clinical trials undertaken in Australia do not require US FDA Investigational New Drug (IND) application approval. 

HREC Process for Public and Private Sites

• Public Hospitals (PHOs): The National Mutual Acceptance (NMA) system allows for single ethical and scientific review for multi-center clinical trials across several states. The approval process typically takes 8-12 weeks, depending on HREC feedback.
• Private Sites: Private HREC services, like Bellberry, offer faster approval timelines, averaging 6-8 weeks, with weekly committee meetings and rapid feedback.

Research Governance

Research governance involves site-specific assessments (SSA) and authorisations necessary for clinical trial commencement. Public sites typically take longer to complete research governance approval (3-6+ weeks), while private sites can approve trials in as little as 1-2 weeks.

Precision for Medicine in Australia — a strategic pairing for the future of clinical trials

With its fast regulatory approvals, government-backed incentives, and world-class infrastructure, Australia is an attractive research destination. As the global demand for novel therapies grows, Australia is well positioned to lead the next wave of clinical advancements, from mRNA and gene therapies to personalised medicine and beyond.

Precision for Medicine, which registered in Australia in 2019, draws on extensive experience through the acquisition of Egan Lee CRO, a company with over 20 years in clinical monitoring and site management. Precision's Australian team offers expertise in clinical operations, project management, regulatory, and medical monitoring across the APAC region.

Assess how Australia may fit within your clinical program.

References

1. Austrade. (n.d.). Australia: A go-to destination for clinical trials. https://www.austrade.gov.au/en/news-and-analysis/analysis/australia-a-go-to-destination-for-clinical-trials (Accessed Nov 12, 2024)
2. Smith, P. (2022, April 29). ‘Invest bravely’: Cancer-fighting giant sets sights on Australia. The Sydney Morning Herald. https://www.smh.com.au/business/entrepreneurship/invest-bravely-cancer-fighting-giant-sets-sights-on-australia-20220429-p5ah8j.html. (Accessed Nov 12, 2024)
3. AusBiotech. (n.d.). Clinical trials. https://www.ausbiotech.org/programs/clinical-trials. (Accessed Nov 12, 2024)
4. Monash University. (2023). Clinical trials in Australia: 2023 review. https://www.monash.edu/__data/assets/pdf_file/0011/3532691/Clinical-trials-in-Australia-2023-review.pdf. (Accessed Nov 12, 2024)
5. Butler, M. (n.d.). Transforming health and medical research in Australia. Australian Government Department of Health and Aged Care. https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/transforming-health-and-medical-research-in-australia. (Accessed Nov 12, 2024)