Clinical Trials in Australia: Challenges and Opportunities

I am currently in Melbourne celebrating National Clinical Trials Week. In the spirit of collaboration across the sector ARCS Australia and the Australian Clinical Trials Alliance are hosting our respective Clinical Summit and Clinical Trials and Registries Symposium in tandem to leverage the common purpose, audience and crossover in our memberships. The ARCS Clinical summit will focus on the gap that exists between clinical trials and the regulations that underpin them. It is a sold out event, and brings together leaders from across the sector to workshop the key issues. It is important to highlight the critical role clinical trials play in advancing therapeutic product development and commercialisation. To put it simply - ?without this part of the sector we would never realise the benefit of health innovation, or have any reason for it to occur in the first place. While Australia has established itself as a global leader in clinical research, particularly in early-phase trials, we can always do better and take our efforts to the next level and strengthen our position in the global clinical trials landscape.

In many respects, Australia is on the front foot in the clinical trials space, with the Australian Government launching major reforms and alignment through the National Clinical Trials Governance Framework and the National One Stop Shop. These initiatives which are designed to harmonise ethics and governance processes across jurisdictions, and address the inefficiencies that have long hindered Australia’s ability to attract later-phase trials. Streamlining these processes is essential for reducing start-up times, improving trial accessibility, and ensuring that Australia remains a competitive and attractive destination for global sponsors.

?Workforce: A Cornerstone of Clinical Trials

The clinical trials space is the backbone of the Australian Medtech and Pharmaceutical sector representing around 10% of the workforce or ~7,700 jobs. As the professional association for the sector, ARCS Australia has taken a leadership role in supporting its growth and development. Through professional development programs aligned with global standards, ARCS provides the training and pathways necessary for workforce members to achieve globally recognised accreditation through our partnership with ACRP - Association of Clinical Research Professionals . These roles, as defined in the National Clinical Trials Governance Framework, such as Clinical Research Associates (CRAs), Clinical Trial Coordinators (CTCs), and Investigators—represent 35% of ARCS Australia’s membership, demonstrating the critical alignment between our professional community and the national framework. However, challenges persist. Workforce shortages, particularly in experienced CRAs and CTCs, threaten the sector's ability to scale and meet growing demand. Through support from the MRFF, ARCS Australia have trained the current generation of CRA’s which are now spread far and wide throughout the sector. While this support has played an important role in Australia’s success in the clinical trial sector, it has also been disrupted through changes in government. Continuing support beyond election cycles is required to develop and professionalise the clinical trials workforce is key if Australia is maintain global competitiveness.

?The Phasing Conundrum

Australia’s has a well-deserved reputation for excellence in early-phase trials. Dedicated phase 1 units like Nucleus Network and CMAX have set global benchmarks for quality and efficiency, attracting private equity investment and international acquisitions (sidenote – Australia has been very good at commercialising these clinical services, but that’s for a future article). While this success underscore Australia’s capabilities, it has also created a potentially skewed view of the landscape with a disproportionate focus on early-phase trials. Later-phase trials (Phases III and IV) are essential for demonstrating real-world impact, supporting regulatory approvals, and ensuring broader patient access to innovative therapies. Australia is often seen as a challenging destination for later-phase clinical trials, despite its strong reputation in early-phase research. Later-phase trials, particularly Phases III and IV, require larger patient cohorts and multi-site coordination, which are areas where Australia faces notable barriers. Challenges such as slower ethics and governance approvals, high operational costs, and difficulties in patient recruitment have made it harder for Australia to compete with regions like Europe, Asia, and North America for these large-scale studies.

Over the past 12 months I have continually heard that “we need to do better to attract later phase trials to Australia”, but yet my LinkedIn feed is full of CRO business development executives attending partnering conferences trying to attract trials to Australia. For example the image below of David Lloyd FMPP who spent over 50 hours over 3 days in partnering booths at BIO Europe demonstrates how hard our CRO's are working to attract inbound trials.

From my conversations and observations, there are systematic issues to later phase trial attraction. It's not as simple as just “doing better” – we collectively need to address the imbalance by improving governance, enhancing patient recruitment, and boosting workforce capacity.

?Patient Recruitment: A Persistent Barrier

One of the most significant challenges in attracting later-phase trials is patient recruitment. Later-phase trials often require large, diverse patient cohorts, and Australia's relatively small, dispersed population poses a recruitment challenge. If a trial requires 150 participants and the incidence of disease is low and there are only 50 prospects for trial recruitment in Australia – it’s simply not going to happen. Trials with slow start-up and patient recruitment times are also more costly to run. However, innovative initiatives like Omico , which leverages genomics to identify patient cohorts in oncology, and 23Strands , which applies similar strategies in reproductive medicine, offer promising solutions. By integrating genomics and advanced patient profiling technologies, these programs are helping to accelerate recruitment, particularly in areas requiring highly specific patient populations. Scaling such initiatives will be vital for improving recruitment rates and strengthening Australia's attractiveness for later-phase trials. Another key driver is commercial competitiveness, market access and reimbursement – Australia is a relatively small market and unlikely to be one of the first markets a new therapeutic product will launch, if it launches at all. Is it ethical to run a later phase clinical trial in Australia for a therapeutic product that will never be commercially available here? Is it worth launching in a relatively small market, when there is uncertainly over market access and reimbursement? These questions are currently being explored the through the HTA review and ARCS is keenly following the direction that these reviews and initiatives are taking.

?A Unified Vision for the Future

The Australian clinical trials sector is at a critical juncture. While our strengths in early-phase trials are globally recognised, it is reassuring that there are some efforts underway (other than “doing better”) that may overcome barriers to later-phase trials and ultimately lead to a balanced and sustainable ecosystem. By aligning with the National Clinical Trials Governance Framework, investing in workforce development, and scaling patient recruitment initiatives like Omico and 23Strands, we can move to the next level and position Australia as a leader in clinical trials across all phases.

The dedication of ARCS members, who are at the core of the clinical trials workforce, carries through to the strength of our professional community. With the current policy actions, the sector has never been so collaborative, especially around the National One Stop Shop. Has there ever been a better time for clinical trials in Australia?

?Tim Boyle CEO, ARCS Australia

Dino Cercarelli Arthur Brandwood Christopher Reid Marisa Petersen Anita van der Meer Anna Megalakakis Navinisha Lee Radhika Butala FMPP Jacqui WATERKEYN Kathryn S. Jacqui Cumming Mark G. David Thomas Matthew Britland Glenn Carter