Recently, we brought together leaders from across Australia’s medical research institutes, university research branches, life sciences funding bodies, and health services for our Clinical Trials Roundtable Series.  

The conversations sparked genuine enthusiasm and a strong, shared commitment to advancing and enhancing the clinical trials sector. Together, participants recognised the urgent need for coordinated action to overcome systemic challenges and seize new opportunities for innovation and collaboration.  

Below, we explore the key themes from these discussions and outline how, together, we can support a more robust and sustainable clinical trials sector. 

Key themes and insights

1. Sector governance, coordination and collaboration

• Australia's clinical trials sector remains fragmented, with duplicated effort and inconsistent processes often seen across multi-centre trials - resulting in inefficiencies and wasted resources.
• The governance and ethics approvals process, particularly for industry-sponsored trials, can be cumbersome, prompting some trials to be withdrawn from Australian sites.
• The National One Stop Shop (NOSS) aims to streamline trial engagement through a single digital portal for researchers, investigators, and trial sites. By entering protocol information once, users will benefit from auto-populated forms, integrated communication with regulatory bodies, and management of State-specific requirements. NOSS, set to replace the ANZCTR, is currently in the consultation phase, offering stakeholders a key opportunity to shape its design and functionality.
• Economic and consumer perspectives should be proactively and consistently embedded into the planning, design and management of clinical trials to ensure relevance, value and impact. 

2. Funding and sustainability

• The current Medical Research Future Fund (MRFF) model should be reviewed to improve coverage of systemic research costs, particularly indirect costs, which are often left unfunded. Funding gaps can impact the quality, scalability and translation of research outcomes. 
• Increasing the MRFF’s annual distribution from the present rate of approximately 2.5% to 4% would help address this issue. A coordinated, sector-wide proposal involving key industry bodies, would strengthen the case for reform.
• There is a need to explore innovative funding models, and to consider revisiting ideas such as the Patent Box Scheme – which, if framed carefully and with precision, could further incentivise the development and commercialisation of life sciences inventions in Australia – and other IP-focussed incentives, to better support commercialisation efforts and long-term sector sustainability.

3. Workforce and capacity

• Workforce instability, particularly among clinical research coordinators and early-career researchers, continues to challenge the sector’s ability to deliver high-quality, timely trials.
• There is an opportunity to leverage AI, remote access technology and flexible trial designs to improve workforce efficiency, reduce administrative burden, and extend trial access to rural and remote populations. The Australian Teletrial Program is leading the way in connecting rural and remote centres to world-class clinical trials.

4. Embedding trials in healthcare 

• Structural barriers continue to limit clinician engagement in research, particularly in private healthcare settings, where employment arrangements differ significantly from those in public hospitals. The traditional trial design of an Institution employing or engaging the Investigator (and so taking on responsibility for the trial undertaken at the Institution) does not always readily fit the private sector model, where the site typically only authorises clinicians to perform care from the clinic’s premises. In these scenarios, private clinics are unlikely to assume responsibility for the conduct of a clinical trial and may be better described as providers of treatment, nursing and equipment services to the Investigator. 
• To embed clinical trials more effectively into routine care, the sector must recognise, reward, and incentivise research participation through improved healthcare funding models and workforce frameworks.

5. Data sharing and innovation

• A common reluctance to share clinical trial data is contributing to inefficiencies, including duplicated trial designs and missed opportunities for collaboration.
• The sector should prioritise the use of national, de-identified datasets to enable broader insights, reduce duplication, and support evidence-based decision-making.
• The use of AI is being explored for participant recruitment, protocol optimisation, and trial management, but wider adoption and integration are needed to fully realise its potential.

Our Roundtable Series has highlighted both the challenges and opportunities facing Australia’s clinical trials sector. By working together, engaging in and supporting key initiatives like NOSS, and pursuing coordinated advocacy and innovation, we can help shape a more efficient, sustainable, and impactful clinical trials ecosystem.

If you’d like to discuss any of these themes, please get in touch.