Evidence map›Paper›PMID 42415187›Full record

ArticleResearch integrity and peer review2026

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

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

Abstract read
In one paragraph

Article in Research integrity and peer review, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Vikneswary BatumalaiThe George Institute for Global Health, UNSW Sydney, Randwick, NSW, Australia. v.batumalai@unsw.edu.au.
Gowri ShivasabesanSchool of Clinical Medicine, UNSW Sydney, Sydney, NSW, Australia.
Cheryl CarcelThe George Institute for Global Health, UNSW Sydney, Randwick, NSW, Australia.
Carole A HarrisThe George Institute for Global Health, UNSW Sydney, Randwick, NSW, Australia.
Sue HauptCentre for Sex and Gender Equity in Health and Medicine, The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.
Eng-Siew KohSchool of Clinical Medicine, UNSW Sydney, Sydney, NSW, Australia.
Angela LiaoThe George Institute for Global Health, UNSW Sydney, Randwick, NSW, Australia.
Shalini K VinodThe Collaboration for Cancer Outcomes, Research and Evaluation (CCORE), Ingham Institute for Applied Medical Research, UNSW Sydney, Sydney, NSW, Australia.
Mei Ling YapThe George Institute for Global Health, UNSW Sydney, Randwick, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSex 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.

methodsA 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).

resultsOf 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%).

conclusionSex 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.

Indexed as

Equity in researchSAGER guidelinesSex and gender reporting

Identifiers

PMID42415187
PMCPMC13343558

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.