Insights from Lachlan Porter MMPP (Chair),Jonathan Kelp, and Claire Finfer

Clinical trials are central to advancing healthcare, yet their journey is rarely smooth. At the ARCS Annual Conference, Lachlan Porter (Northern Sydney Local Health District), Claire Finfer (NSLHD), and Jonathan Kelp (Minter Ellison) shared their diverse experiences and perspectives on the challenges clinical trials face in Australia, and the solutions that might ease the road ahead.

Porter opened the session with a grounded reflection on the current ethics and governance landscape, drawing attention to the often-opaque process once submissions are lodged. While the scheduling and structure of ethics committee meetings are generally well communicated, what happens next can feel like entering a void. Key questions such as whether the submission is going to full committee, who is reviewing the response, and when feedback will be returned, often go unanswered. The result is growing frustration and uncertainty, particularly for international sponsors.

He pointed to New Zealand’s 35-day ethics clock as a model that provides clarity and builds confidence. “Submitting to New Zealand, you know where you stand,” he said. Porter proposed that Australian committees adopt similar fixed timelines, which could offer sponsors greater predictability and support Australia’s global competitiveness.

A recurring issue was the frequent need for amendments shortly after initial submission particularly investigator brochures awaiting final assessments. Porter proposed a two-phase submission process, where conditional approval could be granted while awaiting final test results. This could benefit both sponsors and ethics committees, reducing unnecessary delays and offering a more realistic approach to planning study start-up.

Clair offered a broader view, encouraging the sector to reframe ethics and governance from being perceived as barriers to being seen as facilitators of high-quality research. Drawing on a Taylor Swift lyric to highlight the importance of balance, she argued that the system must ensure rigour and compliance, but not at the expense of goodwill and collaboration. “It’s not about pointing things out for the sake of it. It’s about trust and quality.”

Ethics and governance, she said, should be recognised for their role in ensuring documentation, contracts, and research methods are robust. But this also relies on mutual responsibility. Sites must assess their capacity and risk appetite, and sponsors must invest adequate time upfront in protocol development. Researchers and CROs too often rush to submission with incomplete or inaccurate documents, only to return weeks later with amendments, a cycle that wastes resources and strains relationships.

Jonathan Kelp brought a legal lens to the conversation, illustrating how things can go wrong when expectations are unclear or poorly documented. One case involved a sponsor suing a research institute over recruitment failures, despite the institute screening thousands of records and conducting outreach. The dispute escalated to claims of breach of contract resulting in a multi-million dollar lost profit claim, ultimately ending in mediation. Kelp noted that even where a trial protocol specifies participant numbers, this does not necessarily translate into a legal obligation unless explicitly stated in the agreement.

He also highlighted a UK case that examined the standard of care expected from CROs, especially in managing protocol deviations and site oversight. The judgment acknowledged that deviations are common but reinforced the importance of proactive management and data verification. A third example examined how poor record keeping and ambiguous consent parameters in long-running studies can trigger ethics challenges and ultimately give risk to reputational risk.

The panel concluded with a strong call for better communication and shared responsibility. Ethics and governance timelines are influenced by capacity, but much can be improved with earlier engagement, clearer documentation, and a more consistent national approach.

As one attendee noted, “We are all playing on the same team.” The challenge now is ensuring every player, from sponsor to site, from regulator to researcher understands their role, respects others, and works together to smooth the clinical trial journey for the benefit of Australian patients.