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Language: search.filters.language.EnglishSubject: search.filters.subject.Clinical Research

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  • Item type:Publication,
    Sex Bias in Hand Surgery Research Open PDF 
    (2018)
    Kalliainen, Loree K.
    ;
    Wisecarver, Ian
    ;
    Cummings, Allison
    ;
    Stone, Jennifer
    It has been long recognized that sex-based biases related to participant inclusion exist in research. To help address inequities in research participation, the National Institutes of Health Revitalization Act was passed into law in 1993. Although this act was primarily designed to increase inclusion of females and minorities in research funded by National Institutes of Health, it has also helped raise global awareness of the value of routinely including females and minority groups in research. Subsequent work has demonstrated a continued gap in inclusion of females in medical and surgical research and female animals and cell lines in basic science research. Hand surgeons have recognized that certain conditions have greater incidence in one sex over the other, but there has been no widespread discussion on whether, when, and how sex should be used as an outcomes variable. This review investigated the recent hand surgery literature to assess for equity in inclusion of both sexes in research as well as whether outcomes were analyzed based on sex.
  • Item type:Publication,
    The Persistence of Sex Bias in High-Impact Clinical Research Open PDF 
    (2022)
    Barlek, Mark H.
    ;
    Rouan, Jessica R.
    ;
    Wyatt, Thomas G.
    ;
    Helenowski, Irene
    ;
    Kibbe, Melina R.
    INTRODUCTION: Sex bias is present in clinical research resulting in disparities in the treatment of women. Our objective was to identify the prevalence of sex inclusiveness of participants in human clinical trials after the passage of National Institutes of Health (NIH) and United States Congress policies in 2015 and 2016 to increase female enrollment in clinical research. METHODS: We performed an observational analysis of data from registered clinical trials published in three high-impact biomedical journals from January 1, 2015 to December 31, 2019. RESULTS: One thousand four hundred and forty two manuscripts with 4,765,783 human subjects were included for analysis. Significantly more males (56%) than females (44%) were included in all three journals (P < 0.0001). Sex matching ≥ 80% was found in 24.6% of publications. Industry funded 43.7% of all studies enrolling significantly more males than females (60.8% versus 39.2%, P < 0.0001). NIH funded 10.2% of studies enrolling significantly more females than males (52.7% versus 47.3%, P < 0.0001). North America and Europe contributed 82.6% of the studies with each enrolling significantly more males than females (P < 0.0001). The United States was the country contributing the most studies (36.1%), enrolling significantly more males than females (55.5% versus 45.5%, P < 0.0001). Cardiovascular disease was the subject area of the most manuscripts among medical specialties (19%), enrolling significantly more males than females (64.9% versus 35.1%, P < 0.0001). Studies analyzed by clinical trial phase, type, trial, and allocation enrolled significantly more males than females (P < 0.0001). CONCLUSIONS: Sex bias remains prevalent in human clinical research trials. Improvements have been made in NIH-funded clinical trials; however, this constitutes a small percentage of overall studies.