A recent study from Brown University has raised alarms about the exclusion of pregnant women from clinical drug trials, which poses significant concerns regarding medication safety for both mothers and their children.

Despite ongoing advocacy for greater inclusion, the rates of pregnant participants in drug trials have remained stagnant over the past 15 years.

The study reviewed nearly 90,860 drug trials involving women aged 18 to 45, revealing a startling statistic: only 0.8% included pregnant participants.

Approximately 75% of these trials actively excluded pregnant women, leaving critical questions about the safety and efficacy of medications unanswered.

Specifically, only 19 trials focused on non-infectious chronic conditions, such as anxiety and asthma, included pregnant participants, highlighting a neglect of chronic health issues in this demographic.

This exclusion means that some women may be taking medications without sufficient safety evidence, while others might avoid necessary treatments due to the lack of data.

Randomized control trials are crucial for assessing medication safety and efficacy; however, the ongoing exclusion of pregnant women undermines these evaluations.

Interestingly, about 24% of the studies did not specify whether pregnant participants were included, but further analysis confirmed their general exclusion.

The FDA's regulations mandating safety and efficacy demonstrations were only established in 1962, with the inclusion of women in trials coming later in 1993, underscoring the recent nature of these regulatory changes.

Alyssa Bilinski, an assistant professor at Brown, emphasized that the exclusion of pregnant women complicates the understanding of medication safety during pregnancy.

Bilinski expressed hope that in 30 years, the current lack of evidence regarding medication safety during pregnancy will be viewed as outdated, similar to the previous exclusion of women from trials.