At the 2025 ARCS Annual Conference, Linda Christine, Director of Health and Medical Research for Clinical Trials at the Australian Department of Health, Aged Care and Disability, delivered one of the most anticipated presentations of the program. She outlined Australia’s national reforms in health and medical research, with a spotlight on the National One Stop Shop (NOSS) for clinical trials — a major undertaking aimed at transforming the country’s research operating environment.

The drive to improve Australia’s clinical trials ecosystem began over a decade ago. As a federation, Australia’s research approval systems have long been fragmented, with state and territory-based processes creating inefficiencies. In response, governments have spent years laying the groundwork for a more unified approach. Linda, who has served in both state and federal government roles since the early 1990s, described this as a moment of “cooperative federalism,” where all levels of government come together to address shared challenges.

The NOSS is intended to be a streamlined national platform and portal for clinical trial ethics, governance, and monitoring. Designed to replace the patchwork of state-specific systems, it promises to reduce duplication, improve transparency, and accelerate trial setup timelines. The vision is bold: a single digital system that provides real-time data, integrates ethics and governance approvals, connects with regulatory agencies like the TGA and OGTR, and gives patients and clinicians better access to open trial information.

Linda was clear that the NOSS is not just another IT project. It is a policy reform initiative backed by years of consultation and driven by a strong commitment to improving health outcomes. Over 6,000 stakeholders have already engaged with the project, and the system’s user-centric design has been informed by more than 1,000 individual contributions. “We’ve been listening,” Linda said, “and what we’ve heard is a sector ready for change.”

A core challenge has been variation in research governance across institutions. Despite past progress, site-specific governance remains inconsistent and often slow. Linda acknowledged that while smart and passionate people have created locally optimised solutions, those systems can get in the way of national consistency. The NOSS aims to overcome this by providing a standardised, modular system that supports integration while reducing unnecessary duplication.

The platform also aims to enhance trust in ethics approvals by introducing an accreditation framework for Human Research Ethics Committees (HRECs). Once implemented, this framework will support national mutual acceptance across both public and private sectors, making it easier for sponsors and researchers to work across jurisdictions.

The importance of getting it right is not lost on Linda or her team. The stakes are high. A more efficient system could increase Australia’s competitiveness in attracting global trials, improve access for patients, and deliver better value for government investment. The NOSS promises a 50 percent reduction in trial setup effort and time, and a 60 percent gain in efficiency for trial registration.

However, progress is still dependent on ongoing funding. Linda was candid about the challenges. “The next stages are funding dependent,” she said, “but we have bipartisan support and a clear case for return on investment.” She encouraged stakeholders to continue their unified advocacy and keep raising the profile of the initiative.

The Department is also considering a rebrand for the NOSS, acknowledging that the name may not reflect the scope or ambition of the platform. Suggestions from the sector are welcome.

As the presentation concluded, Linda invited continued engagement. “We are building something world-leading. Let’s make sure it works for everyone — from the researcher to the patient.”

For updates or to be involved, stakeholders can email clinicaltrials.policy@health.gov.au or register for NOSS updates on the Department’s website.