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

Brady E, Nielsen MW, Andersen JP, Oertelt-Prigione S (2021)
Nature Communications 12(1): 4015.

Zeitschriftenaufsatz | Veröffentlicht | Englisch
 
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Autor*in
Brady, Emer; Nielsen, Mathias Wullum; Andersen, Jens Peter; Oertelt-Prigione, SabineUniBi
Abstract / Bemerkung
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. Sex and gender have been associated with differences in SARS-CoV-2 incidence and clinical outcomes and therefore warrant consideration in study designs. Here, the authors assess registered and published clinical COVID-19 studies and find that sex-disaggregated analyses are infrequently presented or planned.
Erscheinungsjahr
2021
Zeitschriftentitel
Nature Communications
Band
12
Ausgabe
1
Art.-Nr.
4015
eISSN
2041-1723
Page URI
https://pub.uni-bielefeld.de/record/2957048

Zitieren

Brady E, Nielsen MW, Andersen JP, Oertelt-Prigione S. Lack of consideration of sex and gender in COVID-19 clinical studies. Nature Communications. 2021;12(1): 4015.
Brady, E., Nielsen, M. W., Andersen, J. P., & Oertelt-Prigione, S. (2021). Lack of consideration of sex and gender in COVID-19 clinical studies. Nature Communications, 12(1), 4015. https://doi.org/10.1038/s41467-021-24265-8
Brady, E., Nielsen, M. W., Andersen, J. P., and Oertelt-Prigione, S. (2021). Lack of consideration of sex and gender in COVID-19 clinical studies. Nature Communications 12:4015.
Brady, E., et al., 2021. Lack of consideration of sex and gender in COVID-19 clinical studies. Nature Communications, 12(1): 4015.
E. Brady, et al., “Lack of consideration of sex and gender in COVID-19 clinical studies”, Nature Communications, vol. 12, 2021, : 4015.
Brady, E., Nielsen, M.W., Andersen, J.P., Oertelt-Prigione, S.: Lack of consideration of sex and gender in COVID-19 clinical studies. Nature Communications. 12, : 4015 (2021).
Brady, Emer, Nielsen, Mathias Wullum, Andersen, Jens Peter, and Oertelt-Prigione, Sabine. “Lack of consideration of sex and gender in COVID-19 clinical studies”. Nature Communications 12.1 (2021): 4015.

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