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- Reporting guidelines recommend that researchers factor the role of sex into animal and clinical studies, but progress in adherence to these guidelines has been slow.<\/li>\n
- Sex-based analyses have led to some key medical discoveries, and researchers are encouraged to examine data for sex differences to enhance study reproducibility and open up questions for scientific pursuit.<\/li>\n<\/ul>\n
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<\/p>\nMedical research funders and publishers are increasingly calling for the role of sex to be considered in preclinical and clinical studies. In a recent Nature <\/em>News Feature article<\/a>, Dr Emily Willingham<\/u><\/a> highlights the importance of reporting sex differences in medical research and examines why progress in this area has been slow.<\/p>\n
Sex as a variable has important health implications. A recent example is COVID-19, which has higher mortality<\/a> in men but affects more women in the form of long COVID<\/a>. Accounting for sex can enhance the scientific rigour and reproducibility of a study, and even if there are no sex-based differences to report, negative findings are still informative.<\/p>\n
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Accounting for sex can enhance the scientific rigour and reproducibility of a study, and even if there are no sex-based differences to report, negative findings are still informative.<\/p>\n<\/blockquote>\n
Yet, since the thalidomide tragedy<\/a> in the late 1950s, women of childbearing age have been under-represented in clinical trials. Progress was made in the early 1990s, when the US National Institutes of Health (NIH<\/a>) began requiring that women are included in clinical research. Both the NIH and EU now call for both sexes to be included in cell and animal studies.<\/p>\n
In 2016, Dr Shirin Heidari<\/a> led the publication<\/a> of the Sex and Gender Equity in Research (SAGER<\/a>) reporting guidelines, with the aim of encouraging authors to consider sex and gender differences in scientific publications. However, progress in adherence to these guidelines has been slow. An analysis<\/a> of 720 papers published in 34 biology journals in 2009 and 2019 found that although the proportion of sex-inclusive studies had risen, the proportion incorporating sex-based analyses had decreased from 50% to 42%. Another study<\/a> reported that even when sex is considered as a variable, treatment effects are often not compared properly between sexes, leading to misinterpretation of data.<\/p>\n
The reasons for the relatively slow uptake of sex inclusion and reporting policies include:<\/p>\n
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- general resistance to change<\/strong> \u2013 some journals assert that the SAGER guidelines are not applicable to their fields<\/li>\n
- cost<\/strong> \u2013 mice studies that include two sexes require more animals, which adds expense<\/li>\n
- complexity of sex<\/strong> \u2013 some researchers argue that a binary definition based on specific anatomy or chromosome numbers is too limiting.<\/li>\n<\/ul>\n
Encouragingly though, since sex inclusion guidelines were put in place, important medical discoveries have been made. One key finding<\/a> is that risk of cardiovascular disease begins to rise at a lower blood pressure in women than in men \u2013 a revelation that came about from a call for studies looking specifically at sex differences in health outcomes. Considering the potential implications for medicine, we hope to see more researchers incorporate sex-specific analyses in their studies.<\/p>\n
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- cost<\/strong> \u2013 mice studies that include two sexes require more animals, which adds expense<\/li>\n
- general resistance to change<\/strong> \u2013 some journals assert that the SAGER guidelines are not applicable to their fields<\/li>\n
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