Designing for Inclusion: TOGA’s Push to Make Lung Cancer Clinical Trials Fairer for All Australians

Prompting Inclusion from the Start

At the heart of TOGA’s new form are questions that can no longer be brushed aside:

“How will the study support diversity in enrolment, and inclusion of people of varying age, race, ethnicity, and gender?

“How will the study address barriers for inclusion of underrepresented populations such as CALD, Aboriginal and Torres Strait Islander peoples, Maori, older patients, and non-metropolitan populations?”

These questions, and others like it, aim to prevent researchers from inadvertently designing trials that disadvantage under-represented groups—an outcome that happens far too often when diversity is treated as an afterthought.

With 1 in 2 Australians are now either born overseas or have a parent born overseas, and more than 1 in 5 Australians who speak a language other than English at home, research teams are now often intimately familiar with the barriers people of CALD background face in accessing clinical trials.

Cancer Australia will also form a National Technical Service that will assist the cancer clinical trial groups funded under the SCCT program in design of trials that are more inclusive for Aboriginal and Torres Strait islander peoples who are diagnosed with cancer.

Where the research team is not already familiar with the barriers faced by a particular under-represented group, they will be encouraged to engage individuals from that group in a process of co-design.

By prompting these considerations during the design phase, TOGA ensures trials are built with inclusion in mind from day one.

Why Inclusion Matters in Clinical Trials

There are many compelling reasons to include historically under-served populations in clinical research:

• Scientific validity: If a trial only includes a narrow group, the results may not apply to the broader population.
• Clinical safety and effectiveness: Different groups can respond differently to treatments. Without testing across diverse populations, we can’t be sure that a new drug is safe or effective for everyone.
• Informed care: When there’s no trial evidence for a particular group, clinicians must rely on opinion instead of data—risking unequal care.
• Practical delivery: Logistical, cultural, psychological, and biological factors all affect how well a treatment can be delivered in real-world settings. We only learn how to deliver treatment effectively if we study a broad population.

Trial Access Shouldn’t Depend on Where you Live

We know that rural, regional and remote patients are under-represented in clinical trials. TOGA’s updated form now asks researchers whether their trial is suitable for teletrials and whether it can open at non-metropolitan sites—a critical step toward increasing equity.

Of course, not every trial can open at every hospital. Some hospitals:

• May not have the standard of care treatment available in their country
• May be unable to deliver critical trial tests or interventions
• May not be accredited under the ACSQHC Clinical Trials Governance Framework that enables the hospital to conduct research
• Might not be projected to recruit enough participants to support trial success

But TOGA’s approach challenges researchers to consciously examine whether the absence of regional or underserved sites is truly necessary—or if it’s the result of unconscious bias or old habits.

A National Push to Improve Clinical Trial Equity

This work supports key goals of the Australian Cancer Plan and TOGA’s SCCT 2024–2027 grant, including to:

• Increase the number of clinical trials in Australia
• Grow participation among Australians affected by cancer
• Develop trials that reflect Australia’s true population
• Improve access to trials for under-served groups
• Expand the number of active clinical trial sites

To guide this effort, TOGA has drawn on best-practice frameworks like TRIAL FORGE INCLUDE and Australian Clinical Trials Alliance. Trial Forge recommends research teams ask themselves:

1. What are the demographics of the population you seek to serve?
2. Do your inclusion/exclusion criteria support recruiting that population?
3. Can you justify any difference between your trial and the population it targets?
4. How will you recruit and retain under-served participants?
5. Is your intervention feasible and accessible across different groups?
6. Are your outcomes relevant to a broad patient population?

Toward a Fairer Future in Lung Cancer Research

Having collected data on the percentage of trial participants that identify with under-represented populations, TOGA is able to evaluate the impact of the intentionally inclusive clinical trial design process in increasing the diversity of recruited clinical trial populations.

Inclusive trials don’t just improve fairness—they lead to better science, stronger evidence, and more confident care decisions. By embedding equity into the trial design process, TOGA is helping ensure future lung cancer trials are built for the real world, not just ideal conditions.

As Professor Keefe said when launching the Australian Cancer Plan:

“The Plan is for all cancers, with a focus on addressing disparity of experience and outcome. It covers every step of cancer care from prevention and early detection through to recovery, living with a chronic disease, or end-of-life care.”

This was supported by comments from Australia’s Health Minister, Mark Butler:

“While cancer outcomes in this country are generally among the best in the world, that’s not true for some people, simply because of who they are or where they live.”

Clinical trials are a necessary part of cancer healthcare and TOGA’s updated clinical trial concept form is one small—but significant—step toward the vision that all people living with cancer deserve the very best care, regardless of factors such as postcode, socioeconomic status, health literacy, cultural background, age or sex, gender or sexual orientation.

The future of lung cancer care should be for everyone—and that starts with who’s included in the research.