Clinical trials are necessary to test the efficacy and safety of experimental drugs, but a recent Brown study found that only 0.8% of studies with women from ages 18 to 45 included pregnant women. Only 19 of the clinical trials for non-infectious chronic diseases included pregnant women.
This discrepancy has downstream effects: If a pregnant woman has a chronic or acute condition that requires treatment, physicians are often left without much research into how treatments could impact pregnant women, said Alyssa Bilinski, an assistant professor of health services, policy and practice and biostatistics, one of the study’s authors.
But this, Bilinski said, needs to change. “We want to make sure that research is as safe as possible,” she added.
Generally, researchers are “incredibly conservative” about conducting studies with pregnant women as subjects, Bilinski explained.
But healthcare providers in certain fields like neurosurgery often avoid operating on pregnant people, because “the vast majority of cases are elective” and physicians hope to “avoid placing the fetus at risk,” according to Wael Asaad, the director of the Functional and Epilepsy Neurosurgery Program and a professor of ophthalmology, visual science, neurosurgery and neuroscience.
There have “been calls for inclusion of pregnant individuals in trials” over the past decade, particularly in studies “not specific to pregnancy,” said Jennifer Unger, an associate professor of obstetrics and gynecology and the division director of research in the department of obstetrics and gynecology at the Women and Infants Hospital. Unger has worked within peripartum research for the last decade.
“We’ve certainly made progress in improving research among pregnant people in the context of pregnancy, but not necessarily including them in drug trials that non-pregnant patients participate in,” she added. “It continues to propagate the health inequities that occur among pregnant individuals.”
But pregnant women are often not included in studies due to limitations with funding, and sponsors are often anxious to provide funding for studies involving pregnant women, Unger said.
With a lack of data including pregnant women comes a lack of treatment, as providers cannot devise and test treatments without proven data. Not all people “understand there are actually real life consequences to patients when we don’t include them in trials,” Unger said. “That has lasting effects on people and on a community of pregnant women.”
The study, conducted by Bilinski and Natalia Emanuel, a research economist at the Federal Reserve Bank of New York, utilized the ClinicalTrials.gov database to research the inclusion of pregnant women in tens of thousands of studies for randomized clinical drug trials.
“This is definitely a problem to think about at the systems level,” Bilinski said. “I think as Brown researchers are designing studies, they, like all researchers, should be thinking broadly about how we can protect pregnant people and their children with research, rather than from research.”
