Recognising International Clinical Trials Day

Clinical Trials: Challenging What’s Possible for Better Patient Outcomes
Exploring what’s next and why research is a shared responsibility
By: Group Executive Manager – Research, Sophie Mepham PhD 

Each year on May 20, we recognise International Clinical Trials Day, marking the day in 1747 when James Lind, a ship’s surgeon in the British Royal Navy, developed the theory that citrus fruit curved scurvy, marking what is widely considered the first recorded clinical trial. His work laid the foundation for evidence-based medicine and the ongoing pursuit of better patient outcomes through research. 

Australia sits at a pivotal moment — with world-class research, growing policy momentum, and a strong appetite for innovation. But to truly realise the potential we need a shared vision, sustained investment and support in governance, and innovative models of care and training to deliver the future of cancer care to more patients, closer to home.

Here’s how.

Precision and personalised medicine is the new standard

Modern oncology is increasingly tailored not just to a cancer type, but to a patient’s unique genetic and molecular profile. Across Australia, trials driven by biomarkers, genomics, and molecular profiling are shifting treatments from ‘one-size-fits-all’ to highly targeted, individualised care.

Initiatives like our partnership with Omico, and leading health networks are embedding molecular screening into clinical workflows, matching patients with trials based on the biology of their disease, not just the site of origin. Theranostics trials are also gaining traction, and highly personalised treatment pathways are being explored.

This approach doesn’t just improve outcomes. It can reduce significant side effects, avoid unnecessary treatments, and connect patients with the most promising treatment options first.

Real-World Evidence: Bridging innovation and implementation

Gone are the days when clinical trials existed in isolation from clinical practice. Today, real-world data (RWD) and real-world evidence (RWE) are critical tools for evaluating how therapies perform outside the controlled environment of a trial.

In Australia, the integration of registry data, electronic health records, and patient-reported outcomes is helping researchers and regulators make more informed, faster decisions. This is especially powerful in rare cancers or underrepresented populations, where traditional trial data is limited.

At Icon we’re investing in RWD and RWE to remain at the forefront of research and patient care, championing joint decision making and ensuring timely access to more trials.

RWE isn’t just a research tool — it’s an equity tool.

Adaptive and decentralised trials: Expanding access

Clinical trial access should not be dictated by a postcode. Yet for too many people, distance, time, and resources remain barriers to participation.

The rise of adaptive trials which evolve based on interim findings paired with decentralised models like the Australian Teletrial Program, are transforming this landscape. Prof Sabe Sabesan, based at Icon Cancer Centre Townsville and working across both public and private sectors, is leading important work in this space, advocating for greater investment in tele trials and a more connected research workforce.

By enabling regional hospitals, telehealth consults, and local sample collection, we’re bringing trials to patients, not the other way around. This model is proving especially powerful in rural and First Nations communities, where historical barriers have contributed to poorer cancer outcomes.

Policy, regulation, and a new era of quality governance

Australia’s policy environment is increasingly aligned with the pace of clinical innovation. Government investment through the Medical Research Future Fund (MRFF), reforms in the Therapeutic Goods Administration (TGA), and a national focus via the Australian Cancer Plan are helping streamline approvals, expand trial eligibility, and support innovation in real-world trial design.

This shift isn’t unique to Australia. Globally researchers and doctors are redefining what ‘good’ looks like.

The transition to ICH GCP E6(R3), the next-generation Good Clinical Practice guidelines is poised to elevate how we approach trial quality, risk management, and oversight. With a stronger focus on fit-for-purpose quality systems, critical data, and participant protection, GCP R3 moves beyond box-ticking compliance toward meaningful, proactive governance.

For trial sponsors, researchers, and health services, this means:

• Embedding risk-based quality management
• Strengthening data integrity frameworks
• Ensuring participant safety remains at the centre of innovation.

It’s a welcome evolution and one that positions Australia to lead in delivering globally credible, patient-centred trials.

Diversity in clinical trials – it’s moral and scientific

For cancer care to be effective, it must be inclusive. Yet certain populations including older adults, Aboriginal and Torres Strait Islander peoples, culturally diverse groups, women of colour, and those with multiple health conditions remain underrepresented in clinical research.

This is not just an issue of fairness. It affects data quality, generalisation of biology, and ultimately the real-world effectiveness of new treatments.

Forward-thinking trial designs are now reconsidering eligibility criteria, embracing flexible participation models, and partnering directly with communities to build trust and break down barriers. At Icon, we’re looking into how we can improve diversity in our trial patient recruitment and ensure more people are represented and cared for.

It starts with real people

Innovation in cancer care doesn’t just start in the lab, it starts in the clinic, with real people, real decisions, and real action.

Australia has the expertise, the systems, and the opportunity. What we need now is sustained support, investment in the national clinical trials workforce through standardised training opportunities and agreed competencies, and vision to ensure every patient, everywhere, has access to the future of cancer care, today.

I’m so proud to lead a team of experienced, talented and compassionate researchers and work alongside leading clinicians who integrate research into their clinical practice. At Icon research is part of our DNA and the model we have developed and continue to build on allows us to introduce quality and leading trials into New Zealand, Singapore, Malaysia, the UK and beyond.

Research is a shared responsibility. The journey may be complex and challenging, but the impact is transformative. Together, we’re laying the foundation for a brighter future.

To learn more about how you can support clinical trials make a donation to Icon Cancer Foundation’s Appeal: Donate to Appeal – May 2025 – Icon Cancer Foundation