A recent analysis conducted by researchers at the Brown University School of Public Health has uncovered a troubling trend: pregnant women are often excluded from clinical trials that evaluate the safety of medications.
This exclusion poses significant health risks for both mothers and their newborns.
Research Findings
The findings, published in the American Journal of Obstetrics and Gynecology, draw upon an extensive dataset of 90,860 drug trials involving women aged 18 to 45 over the last 15 years.
Shockingly, only 0.8% of these trials included pregnant participants.
Moreover, roughly 75% of the studies specifically barred pregnant women from taking part, highlighting a critical lack of information about the safety and efficacy of various treatments for this population.
Alyssa Bilinski, an assistant professor at Brown specializing in health services policy and biostatistics, pointed out that this exclusion makes it challenging to assess whether medications are safe for use by expectant mothers and their children.
She raised concerns about the risks faced by these women when they must rely on incomplete data—some may take medications that could harm them or their babies, while others might forgo beneficial treatments due to uncertainty surrounding their safety.
Critical Lack of Inclusion
The review also noted that approximately 24% of the examined studies did not specify whether pregnant women were included.
However, follow-up analyses indicated that these individuals were usually absent.
Among the few studies that did include pregnant participants, the research largely focused on issues related specifically to pregnancy and childbirth, ignoring chronic health conditions like asthma and diabetes, which significantly impact this group.
The researchers identified only 19 clinical trials that encompassed pregnant individuals while exploring non-infectious chronic conditions such as anxiety, depression, and asthma.
Bilinski emphasized that, although there are valid concerns about including pregnant women in research, the lack of sound information available to them could lead to even greater harm.
Historical Context and Future Implications
Despite continued advocacy for greater representation of pregnant women in drug trials, the proportion of such participants has not improved over the past 15 years.
Randomized controlled trials, the gold standard for evaluating drug safety and effectiveness, involve administering a treatment to one group while withholding it from another, thus revealing critical insights about a drug’s efficacy and side effects.
This lack of inclusion leaves significant gaps in knowledge about how medications affect pregnant individuals, often leading to uncertainty in treatment decisions.
Recently, innovative technologies have emerged to address this issue; for example, AI identifies hidden pregnancy risks by analyzing large datasets and detecting patterns that may not be evident in traditional studies.
While these advancements hold promise, experts emphasize that they should complement, rather than replace, well-designed clinical trials involving pregnant participants.
Bilinski also remarked on the historical context of these regulations: it wasn’t until 1962 that the U.S. Food and Drug Administration mandated drug manufacturers to demonstrate the safety and effectiveness of their products.
Furthermore, it took until 1993 for requirements to include women in these trials to be established.
This relatively recent shift underscores the importance of continual progress in the field, with an aspiration that future generations will view the current gaps in medication safety evidence during pregnancy as troubling relics of the past, akin to the previous exclusion of women from clinical studies.
Bilinski collaborated on this crucial study with Natalia Emanuel, a research economist at the Federal Reserve Bank of New York, employing advanced data analysis techniques, including natural language processing, on information sourced from ClinicalTrials.gov.
Source: ScienceDaily