Australian medical research that considered sex as a biological variable: a meta-analysis

Author:

Ryan JanelleORCID,Landen ShanieORCID,Harley VincentORCID

Abstract

AbstractSubjects in medical research have predominantly been male (1). Women experience 50-75% more adverse drug responses (2) resulting in withdrawn medications (3). While sex differences in metabolism, disease and treatment response are increasingly recognised, sex-informed medicine is lagging. In 2016, USAs National Institutes of Health (NIH) formulated the Sex as a Biological Variable policy (4), stating that grant recipients must consider sex in experimental design, planning, analysis and reporting of their findings. Australian data is lacking on the inclusion of both males and females as well as appropriate analysis of sex differences.We analysed the 219 Medical Journal of Australia (MJA) research articles over 2019-2023 (Box 1). We tallied when; i) both males and females were included in the study, ii) sex differences were reported and/or considered, and iii) the analysis was appropriate to support sex-related claims.We found that articles published in MJA are including males and females, however testing of sex differences is uncommon and appropriate statistical analysis is lacking. We hope that this article will bring attention to this fundamental issue and improve future efforts to investigate sex differences.

Publisher

Cold Spring Harbor Laboratory

Reference14 articles.

1. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

2. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century

3. Heinrich, J. , et al., Drug safety: most drugs withdrawn in recent years had greater health risks for women. A letter to The Honorable Tom Harkin, The Honorable Olympia J. Snowe, The Honorable Barbara A. Mikulski, United States Senate, The Honorable Henry Waxman, House of Representatives. Washington DC: United States General Accounting Office, 2001.

4. Considering sex as a biological variable in preclinical research

5. A 10-year follow-up study of sex inclusion in the biological sciences

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