Women not underrepresented in clinical trials

A Dutch advocacy group claims that women receive worse care than men, because pharmaceutical companies do not sufficiently test their medicines on women. A shocking message, for which there is no evidence. In fact, The Investigative Desk found that in reality, more than 60 percent of patients in last year’s phase 3 trials were female.

Shortly before covid-19 hit the Netherlands, two members of Dutch parliament demanded that clinical research on women should be structurally improved. The letters to the Minister for Healthcare were prompted by the Dutch advocacy  group Women Inc., which has been keeping this topic on the public agenda for the last five years.

According to the organisation, pharmaceutical researchers neglect women when developing  new medicines, testing medicines mostly on men. As a result, women would receive worse care than men. Moreover, women would suffer more adverse drug reactions.

According to our investigation , these claims lack substantial evidence. We investigated all medicines with a ‘new active substance’ (24 in total) that were accepted by the European Medicines Agency (EMA) between spring 2019 and spring 2020. Of the total number of patients that took part in phase-3 clinical trials, 63 percent were female. Almost three quarters of the trials were subjected to sex specific analysis.

According to several clinical researchers, the effect of medicines differ only marginally between men and women. The fact that women report more adverse drug events is not necessarily related to the clinical research methodology: women communicate differently about their health, take more medication in general and perhaps notice and report adverse drug events at an earlier stage.

Read the full article in the Dutch Journal of Medicine (NTvG).