Oral Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

Sex and gender reporting in Australian cancer clinical trials: Are we doing enough? (126149)

Vikneswary Batumalai 1 2 , Gowri Shivasabesan 3 4 , Cheryl Carcel 1 3 , Carole A Harris 1 5 6 , Sue Haupt 7 , Eng-Siew Koh 8 9 , Shalini Vinod 2 8 9 10 , Mei Ling Yap 1 2 8 9 11
  1. The George Institute for Global Health, University of New South Wales Sydney, Sydney, NSW, Australia
  2. The Collaboration for Cancer Outcomes, Research and Evaluation (CCORE), Ingham Institute, UNSW, Sydney, NSW, Australia
  3. School of Clinical Medicine, UNSW, Sydney, NSW, Australia
  4. Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW, Australia
  5. St George Hospital, Kogarah, NSW, Australia
  6. St George and Sutherland Clinical Campuses, UNSW, Sydney, NSW, Australia
  7. Centre for Sex and Gender Equity in Health and Medicine, The George Institute for Global Health, UNSW, Sydney, NSW, Australia
  8. Department of Radiation Oncology, South Western Sydney Local Health District, Sydney, NSW, Australia
  9. South Western Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia
  10. Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, NSW, Australia
  11. School of Medicine, Western Sydney University, Campbelltown, NSW, Australia

Objective: The Sex and Gender Equity in Research (SAGER)1 guidelines aim to improve sex and gender reporting in research. However, their implementation in scientific publications remains limited, and reporting continues to fall short. This study assesses the adherence of Australian cancer clinical trials to the SAGER guidelines.

Methods: A systematic search of Embase was conducted to identify peer-reviewed articles published between 2014 and 2024, focusing on all phases of randomised controlled trials in cancer involving adult participants. Eligible studies were either conducted in Australia or led by Australian investigators. Trials focusing on cancers predominantly or exclusively affecting one sex (breast, cervical, ovarian, uterine/endometrial, prostate, testicular and penile cancers) were excluded. Adherence to individual SAGER guideline items was assessed.

Results: Of the 629 articles screened, 128 met the inclusion criteria. Appropriate use of the terms sex/gender was observed in 45% (n=58/128) of studies. None of the studies described how sex or gender were determined. Consideration of sex/gender in the study design was reported in only 16% (n=20). Whilst 87% (n=111) provided an overall sex/gender breakdown, only 10% (n=13) reported a complete breakdown across all demographic or baseline characteristics. Sex/gender-based analyses, regardless of outcomes, were conducted in 28% (n=36), and only 11% (n=14) discussed the potential implications of sex or gender on study findings or the generalisability of results across sexes/genders.

Conclusion and implications: Sex and gender reporting remains suboptimal in contemporary Australian cancer clinical trials, with limited consideration given to study design, analysis, and interpretation. Our ongoing work is examining reporting trends before and after the release of the SAGER guidelines in 2016 to assess their impact. Strengthening institutional policies and peer-review processes to support the routine implementation and adherence to the SAGER guidelines will be essential for advancing equity in cancer research and care.

  1. Heidari, S., Babor, T.F., De Castro, P. et al. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev 1, 2 (2016)