What sets Australia aside in the world of competitive clinical trials?

For a country of less than 30 million people, Australia has always punched above its weight in the medical field, boasting a world-class research infrastructure, state-of-the-art facilities and equipment, as well as a highly trained and experienced clinical and research workforce.

This has led to over 1200 medical technology and pharmaceutical companies employing over 68,000 people across the country.

But how did we get here, and how can we make sure we maintain our status? Australian Clinical Trials Alliance COO, Dino Cercarelli, says there are a multitude of factors ensuring Australia is part of any trial conversation, in particular our strong multicultural community.

ACTA's Dino Cercarelli “Australia offers an ethnically diverse participant pool with 30% of the Australian population born overseas. A stable socio-political environment that supports constancy from recruitment right through the treatment, analysis and evaluation phases,” Mr Cercarelli said.

“Clinical trials in Australia follow recognised international standards of conduct, ensuring confidence and recognition of scientific conclusions reached. Local regulatory regimes are pragmatic and efficient, and the government provides support structures while encouraging industry investment.”

To ensure competitiveness, the Australian Government offers up to 43.5 per cent R&D tax incentives – which is up to 60 per cent cheaper than the US.

But for these incentives, could more potentially be done at the bureaucratic level?

“Cost efficiency certainly impacts Australia’s competitiveness in the international clinical trials landscape, and a range of government-led measures can increase competitiveness by further supporting research capacities, as well as pharmaceutical and biotechnology industry investments,” said Mr Cercarelli.

“The Australian Government is running a number of initiatives to strengthen clinical trial processes and healthcare access across Australia. Efforts that are already underway include the National One Stop Shop, HeSANDA, the National Clinical Trials Governance Framework and the Australian Teletrials Program.”

“The National Clinical Trials Governance Framework and the National One Stop Shop, once implemented, will improve time to trial start-up, workforce capacity and engagement with sponsors.”

ACTA is acutely aware of how important their role is to act as a conduit for the many parts of clinical trial activity in this sector.

Trial activities in Australia are supported by 50+ clinical trial networks (CTNs), 20 coordinating centres (CCs) and almost 100 clinical quality registries (CQRs). The Australian Clinical Trials Alliance (ACTA) was formed to support and promote CTNs, CCs and CQRs, and connect clinical researchers with governments, health care policymakers and consumers in the clinical trials space across the Australian health system.

But in addition to hospital-based care models in metropolitan areas, Australia also supports access to regional, rural, and remote communities via rural general practice research networks and telehealth-based care.

One example is The Australian Teletrials Program: a $75.2million government funded initiative that aims to establish greater access to clinical trials by connecting smaller, rural based care centres to primary clinical trial sites via telehealth. ACTA supports the Australian Teletrials Program by delivering capacity building and education opportunities for Clinical Trial Networks and Coordinating Centres to assist the rollout of Teletrials across regional, rural and remote sites and across all therapeutic areas.

Additionally, there are targeted funding rounds with additional focus on activities for rural, regional and remote Australians, as well as promoting the equity and inclusion of First Nations People living outside metropolitan centres.

But the question must be asked, given all this, how strong exactly is Australia in such a competitive global market? The answer is, very.

Based on data from The Association of the British Pharmaceutical Industry, Australia ranks 3rd in the world for Phase I trials, 4th in the world for Phase II trials and 11th in the world for Phase III trials.

Australia is highly competitive in its research facilities and workforce, and aligns to international regulatory frameworks and ethics committees, instilling confidence in its research results worldwide.

Importantly, Government funding and support is strong, led by the National Health and Medical Research Council (NHMRC) as the Australian Government’s primary health and medical research funding agency, that promotes various initiatives, for instance the Medical Research Future Fund (MRFF): a $20 billion long-term investment supporting health and medical research.

For all these benefits, there are two keys in ACTA’s mind to ensure Australia stays near the top. Firstly, to continue to promote awareness and education of the public, healthcare professionals and decision makers about the benefits of clinical trials in health care, which contribute to increased participation, engagement, and better health outcomes. Secondly, embedding clinical trials into the health system to better support evidence-based care.

“In 2024, we are pursuing activities to connect our members and the broader investigator-initiated trial sector with governments, healthcare policymakers and consumers to streamline and support the conduct of and access to clinical trials across the Australian health system,” Mr Cercarelli said.

“ACTA is pursuing the development, and implementation of national frameworks to expand the capacity, capability and effectiveness of the clinical trial landscape in Australia.”