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Lack of consideration of sex and gender in COVID-19 clinical studies

Author

Listed:
  • Emer Brady

    (Aarhus University)

  • Mathias Wullum Nielsen

    (University of Copenhagen)

  • Jens Peter Andersen

    (Aarhus University)

  • Sabine Oertelt-Prigione

    (Radboud University Medical Center
    University of Bielefeld)

Abstract

Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences influence the frequency and severity of pharmacological side effects. A large number of clinical trials to develop new therapeutic approaches and vaccines for COVID-19 are ongoing. We investigated the inclusion of sex and/or gender in COVID-19 studies on ClinicalTrials.gov, collecting data for the period January 1, 2020 to January 26, 2021. Here, we show that of the 4,420 registered SARS-CoV-2/COVID-19 studies, 935 (21.2%) address sex/gender solely in the context of recruitment, 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting, and only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable. Just eight (17.8%) of the 45 COVID-19 related clinical trials published in scientific journals until December 15, 2020 report sex-disaggregated results or subgroup analyses.

Suggested Citation

  • Emer Brady & Mathias Wullum Nielsen & Jens Peter Andersen & Sabine Oertelt-Prigione, 2021. "Lack of consideration of sex and gender in COVID-19 clinical studies," Nature Communications, Nature, vol. 12(1), pages 1-6, December.
  • Handle: RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-24265-8
    DOI: 10.1038/s41467-021-24265-8
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    Cited by:

    1. Mendolia, Silvia & Suziedelyte, Agne & Zhu, Anna, 2022. "Have girls been left behind during the COVID-19 pandemic? Gender differences in pandemic effects on children’s mental wellbeing," Economics Letters, Elsevier, vol. 214(C).
    2. Jennifer Y. Kim & Alyson Meister, 2023. "Microaggressions, Interrupted: The Experience and Effects of Gender Microaggressions for Women in STEM," Journal of Business Ethics, Springer, vol. 185(3), pages 513-531, July.

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