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

University of Bielefeld; Radboud University; University of Copenhagen; Aarhus University;

4,500 clinical studies shows: Only four percent of the evaluated studies primarily include gender as aspects in their analysis.

  • Disziplin: Sozial, Weitere
  • Forschungsmethode: Quantitativ
  • Forschungsdesign: Sekundäranalyse, Weitere Daten (z. B. Einzelinterview, Web Scraping, Laborwerte etc.)
  • Erhebungsstatus: Erhebung abgeschlossen, Ergebnisse veröffentlicht, Daten zugänglich

Ziele der Studie

During the pandemic it became clear that women and men are affected differently by corona disease. Men are more often affected by the course of the disease, have to be treated more often in hospital and ultimately die more often in connection with the virus. The reasons for this have not yet been fully researched. But one possible consequence would be that women and men would have to be treated differently medically.
Therefore the aim of the researchers was to point out that only four percent differentiated between different genders.

Studiendesign/Umsetzung

Data was obtained through a query of the relational database “Aggregate Analysis of ClincalTrials.gov” (AACT)33 on 26 January 2021. AACT contains all publicly available ClinicalTrials.gov data.

The analysis covered registrations with a starting or submission date (if no starting date was available) between 1 January 2020 and 26 January 2021. They removed duplicate registrations and studies listed as ‘Withdrawn’ or ‘No longer available’, leaving them with a final sample of 4420 studies.

ClinicalTrials.gov mandates researchers to state the sexes eligible for their study by selecting one option from a pre-defined list (‘All’, ‘Male’ or ‘Female’). The researchers used this data element to identify single-sex study designs. For registrations open to ‘All’ sexes, they identified attention to sex/gender by searching for the following terms (and their plurals): sex, gender, woman, female, man, male, girl, boy, pregnan*, and transg*.

Datenverfügbarkeit

Source data for this study was gathered from the following public repositories; ClinicalTrials.gov study registration data from the Aggregate Analysis of ClincalTrials.gov database (https://aact.ctti-clinicaltrials.org/) and publications from the PubMed database of biomedical literature (https://pubmed.ncbi.nlm.nih.gov/). Data on our final study and paper samples, which supports our main results, is available in an Excel file in a public Github repository at https://github.com/bradyemer/Sex-gender-in-COVID-19-trials (https://doi.org/10.5281/zenodo.4772598 ).

Weiterführende Links

Pressemitteilung
https://idw-online.de/de/news772306

Veröffentlichung
https://www.nature.com/articles/s41467-021-24265-8#Abs1