A new investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), the University of Liverpool and the Guardian newspaper finds that women continue to be ‘severely under-represented’ in clinical trials, with 67% more male-only medical research trials than female-only trials being carried out in the UK.
Both sexes were included in most trials (90%), but male-only studies (6.1%) were nearly twice as common as female-only trials (3.7%). 282 male-only trials were carried out in 2019-23; versus 169 female-only trials.
Pregnant and breastfeeding women were especially under-represented; they were involved in just 1.1% and 0.6% of trials respectively.
Dr Amy Brenner, an assistant professor in the clinical trials unit at the London School of Hygiene & Tropical Medicine, told the Guardian: “It is particularly concerning … this under-representation means there is a lack of evidence on the safety and effectiveness of many interventions (for) women.”
Prof Anna David, the director of the EGA Institute for Women’s Health at UCL, told the Guardian: “There is this perception that women, pregnant women and breastfeeding women do not want to participate in clinical trials and therefore they are usually not considered as potential participants, even in phase 3 clinical trials. This is not the case.”
“Women and their healthcare providers are therefore having to make decisions about whether to take a drug in a vacuum of evidence, which is not ethical.”
David was especially concerned that only 2.2% of trials focused on reproductive and childbirth issues. She said: “pregnancy conditions such as pre-eclampsia, preterm labour, and placental insufficiency leading to foetal growth restriction are major diseases with no current treatments.”
Cancer trials made up a third (the largest group) of all 4,616 clinical trials submitted to the MHRA between 2019 and 2023, while other major conditions lagged behind. Trials for conditions such as chronic pain and mental health disorders (both of which disproportionately affect women) were among the least common, despite their significant public health impact.
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