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Background <p>Sex and gender influence cancer incidence, treatment response, and outcomes, yet reporting of these variables remains inconsistent in clinical research. Australia represents a distinct research governance context, where sex and gender considerations are recommended but not systematically embedded in regulatory oversight, and where no national evaluations of reporting in cancer trials exist. By examining Australian cancer randomised controlled trials (RCTs) published from 2014-2024, this study addresses a critical evidence gap and extends prior international assessments by providing the first national-level analysis of reporting practices in relation to the Sex and Gender Equity in Research (SAGER) guidelines.</p> Methods <p>A review of RCTs conducted in Australia or led by Australian investigators and published between January 2014 and October 2024 was undertaken. Studies were assessed for adherence to key SAGER criteria, including correct use of terminology, reporting of sex/gender in abstracts and tables, consideration in study design, inclusion of sex/gender-based analyses, and discussion of implications. For temporal comparisons, the introduction of the SAGER guidelines in 2016 was used as the cut‑off, with trials grouped as pre‑SAGER (2014–2016) and post‑SAGER (2017–2024).</p> Results <p>Of 128 eligible studies, none reported how sex or gender was defined. Overall, 50% used appropriate terminology, 14% reported sex/gender in abstracts, 16% considered these variables in design, 28% conducted sex/gender-based analyses, and 11% discussed implications. Post-SAGER, there was an increase in appropriate terminology use (from 39% to 54%), sex/gender breakdown in abstracts (from 9% to 16%), and demographic tables with separate rows for males and females (from 41% to 69%). However, these tables typically provided only overall sex counts; only 10% of studies presented a complete sex/gender breakdown across all baseline characteristics. References to sex/gender relevance in introductions declined (12% to 2%), consideration in study design decreased (21% to 14%), and sex/gender-based analyses dropped (44% to 22%).</p> Conclusion <p>Sex and gender reporting in Australian cancer RCTs remains inconsistent and suboptimal. While modest gains were achieved post-SAGER, stronger editorial oversight, funding mandates, and researcher education are needed to ensure equitable, rigorous, and generalisable cancer research.</p>

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Sex and gender reporting in Australian cancer clinical trials: are we doing enough?

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月8日

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  • Vikneswary Batumalai,
  • Gowri Shivasabesan,
  • Cheryl Carcel,
  • Carole A. Harris,
  • Sue Haupt,
  • Eng-Siew Koh,
  • Angela Liao,
  • Shalini K. Vinod,
  • Mei Ling Yap

摘要

Background

Sex and gender influence cancer incidence, treatment response, and outcomes, yet reporting of these variables remains inconsistent in clinical research. Australia represents a distinct research governance context, where sex and gender considerations are recommended but not systematically embedded in regulatory oversight, and where no national evaluations of reporting in cancer trials exist. By examining Australian cancer randomised controlled trials (RCTs) published from 2014-2024, this study addresses a critical evidence gap and extends prior international assessments by providing the first national-level analysis of reporting practices in relation to the Sex and Gender Equity in Research (SAGER) guidelines.

Methods

A review of RCTs conducted in Australia or led by Australian investigators and published between January 2014 and October 2024 was undertaken. Studies were assessed for adherence to key SAGER criteria, including correct use of terminology, reporting of sex/gender in abstracts and tables, consideration in study design, inclusion of sex/gender-based analyses, and discussion of implications. For temporal comparisons, the introduction of the SAGER guidelines in 2016 was used as the cut‑off, with trials grouped as pre‑SAGER (2014–2016) and post‑SAGER (2017–2024).

Results

Of 128 eligible studies, none reported how sex or gender was defined. Overall, 50% used appropriate terminology, 14% reported sex/gender in abstracts, 16% considered these variables in design, 28% conducted sex/gender-based analyses, and 11% discussed implications. Post-SAGER, there was an increase in appropriate terminology use (from 39% to 54%), sex/gender breakdown in abstracts (from 9% to 16%), and demographic tables with separate rows for males and females (from 41% to 69%). However, these tables typically provided only overall sex counts; only 10% of studies presented a complete sex/gender breakdown across all baseline characteristics. References to sex/gender relevance in introductions declined (12% to 2%), consideration in study design decreased (21% to 14%), and sex/gender-based analyses dropped (44% to 22%).

Conclusion

Sex and gender reporting in Australian cancer RCTs remains inconsistent and suboptimal. While modest gains were achieved post-SAGER, stronger editorial oversight, funding mandates, and researcher education are needed to ensure equitable, rigorous, and generalisable cancer research.