Background: Precision cancer care can only be equitable if trial populations reflect the diversity of those affected by cancer. Without accurate demographic data, inequities remain invisible and cannot be addressed. We assessed how Australian cancer clinical trials reported critical dimensions of diversity - cultural, ethnic and/or Indigenous background, and sex/gender - over the past decade.
Methods: A systematic search of Embase and the Australian and New Zealand Clinical Trials Registry identified peer-reviewed adult cancer randomised controlled trials (RCTs) published 2014–2024 that were predominantly conducted in Australia or led by Australian investigators. Reporting of cultural variables (ethnicity, language, country of birth, Indigenous heritage) was assessed across 265 trials. Sex/gender reporting was assessed in 128 trials using the Sex and Gender Equity in Research (SAGER) guidelines.
Results: Only 35% of trials reported any cultural diversity: 17% reported ethnicity/race (most commonly as "Caucasian" or "Asian"), 16% reported country of birth, and 11% language spoken at home. Just 4% (n=11) reported whether participants identified as Aboriginal or Torres Strait Islander/First Nations. Two variables were associated with diversity reporting: larger study size (OR=4.07, 95%CI:1.90-8.70, p<0.001) and the presence of industry funding (OR=2.84, 95%CI: 1.14-7.07, p <0.001). Sex/gender reporting was similarly suboptimal: appropriate terminology was used in only 50% of studies, with sex/gender-based analyses reported in just 28%. Following the introduction of SAGER guidelines (2016), terminology and demographic table reporting improved modestly, but explicit consideration of sex/gender in study design and sex/gender-based analyses declined.
Conclusion: Australian cancer trials systematically under-report the demographic data needed to identify and address inequities, with Indigenous participation amongst the least visible. We advocate for a minimum required dataset - cultural demographic indicators, Aboriginal and Torres Strait Islander identification, and sex/gender variables- alongside stronger editorial and funder mandates, to ensure evidence is generalisable and precision care is genuinely accessible to all Australians.