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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.
  • Brady E; Danish Centre for Studies in Research and Research Policy, Aarhus University, Aarhus, Denmark.
  • Nielsen MW; Department of Sociology, University of Copenhagen, Copenhagen, Denmark.
  • Andersen JP; Danish Centre for Studies in Research and Research Policy, Aarhus University, Aarhus, Denmark.
  • Oertelt-Prigione S; Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, Netherlands. sabine.oertelt-prigione@radboudumc.nl.
Nat Commun ; 12(1): 4015, 2021 07 06.
Article in English | MEDLINE | ID: covidwho-1298840
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Clinical Studies as Topic / COVID-19 Limits: Female / Humans / Male Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-021-24265-8

Full text: Available Collection: International databases Database: MEDLINE Main subject: Clinical Studies as Topic / COVID-19 Limits: Female / Humans / Male Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-021-24265-8