Most COVID Trials Ignore Gender Despite Differences in Disease Impact
Most COVID-19 trials fail to take gender into account in their design and data analysis despite the virus’s different effect on men and women, a new study reports.
The majority of the 4,420 trials studied (66.7 percent) made no mention of gender in the information they submitted to ClinicalTrials.gov, and only 5.4 percent of the trials planned to have gender-matched or representative subgroups and samples, according to the analysis published this month in Nature Communications. In addition, the researchers found that 21 percent of trials only took gender into account when choosing trial participants and only 4 percent planned to use gender as a variable in their analyses.
The team of Danish and Dutch researchers representing Aarhus University, the University of Bielefeld, the University of Copenhagen and Radboud University Medical Center theorized that the intense time pressures the pandemic posed on trials could have been initially to blame for the low numbers of gender considerations in research. But as the pandemic played out and more was learned about the disease’s differing effects on men and women, the focus hardly shifted.
Stressing the importance of accounting for gender in clinical trials, the researchers called the consideration of the differences “an essential step toward more personalized healthcare” and warned that failure to do so may lead to unforeseen, serious side effects later.
Read the full study here: https://go.nature.com/36DJUVB.