Lack of consideration of sex and gender in COVID-19 clinical studies
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Lack of consideration of sex and gender in COVID-19 clinical studies. / Brady, Emer; Nielsen, Mathias Wullum; Andersen, Jens Peter; Oertelt-Prigione, Sabine.
I: Nature Communications, Bind 12, Nr. 1, 4015, 12.2021.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Lack of consideration of sex and gender in COVID-19 clinical studies
AU - Brady, Emer
AU - Nielsen, Mathias Wullum
AU - Andersen, Jens Peter
AU - Oertelt-Prigione, Sabine
N1 - Funding Information: E.B. and J.P.A. are supported by a grant from the Aarhus University Research Foundation (no. AUFF-F-2018-7-5). Publisher Copyright: © 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85109281799&partnerID=8YFLogxK
U2 - 10.1038/s41467-021-24265-8
DO - 10.1038/s41467-021-24265-8
M3 - Journal article
C2 - 34230477
AN - SCOPUS:85109281799
VL - 12
JO - Nature Communications
JF - Nature Communications
SN - 2041-1723
IS - 1
M1 - 4015
ER -
ID: 286328476