Study shows OB-GYN research lacks racial, ethnic inclusivity

All non-white racial and ethnic groups are underrepresented in OB-GYN clinical trials, reports a new Northwestern Medicine study.

Since clinical trials and scientific publications inform clinical care, failing to report the race and ethnicity of study participants and conducting homogenous, non-representative research has a negative impact on OB-GYN care, said corresponding author Dr. Jecca Steinberg.

All non-white racial and ethnic groups are underrepresented in OB-GYN clinical trials, the study found

“We know that race and ethnicity reporting and representation in research are critical parts of health equity, public health and social justice,” said Steinberg, a third-year medical resident in the department of obstetrics and gynecology at Northwestern University Feinberg School of Medicine. “This is one of the first papers to comprehensively look at OB-GYN clinical trials, and the findings offer a critique on how the field can improve as a whole, as well as within subspecialties.”
The study was published Dec. 21 in JAMA Surgery. It examined racial and ethnic representation in all U.S. OB-GYN clinical trials and subsequent research publications between 2007 and 2020.

Tweet this quoteFailing to report the race and ethnicity of study participants and conducting homogenous, non-representative research has a negative impact on OB-GYN care.”
Dr. Jecca Steinberg
Corresponding study author
The absence of diverse representation in clinical trials can be harmful on several levels, Steinberg said. For example, a recent study from Northwestern OB-GYN alumnus Dr. Kemi Doll found the gold standard for endometrial cancer screening was based on research and trials that predominantly included white participants.

“Dr. Doll’s research demonstrated the tools we as clinicians in the OB-GYN field have to diagnose and evaluate endometrial cancer were biased and led to unacceptably low sensitivity in the Black female population,” Steinberg said. “The lack of research participant diversity has had direct negative consequences.”

More about the study
Of the 1,300 U.S. OB-GYN clinical trials with results on ClinicalTrials.gov and 1,147 clinical trial publications between 2007-2020, only 51% of trials and 75% of publications reported race and ethnicity data. Underrepresentation varied by race and ethnicity, funder and subspecialty, the study found. Obstetric and family planning trials had the most diversity of the subspecialties while gynecologic-oncology had the worst representation of Black and Latinx participants.

There has been increasing awareness that maternal morbidity and mortality disproportionately impacts Black and Latinx communities, but this study found all OB-GYN subspecialities—not just areas pertaining to pregnancy—are lacking racial and ethnic representation in clinical trials and research publications.

“This issue is pervasive across the entire field,” Steinberg said. “Diverse representation in research is critically important because clinical trials drive innovation in the field, including informing the newest practices and therapies. Clinical trials often offer access to the best cutting-edge therapies, and a lack of inclusion prevents certain populations from benefiting from trial participation.”

Much of the current scientific literature about health disparities focuses on how Black and Latinx populations compare to white populations. This study examined underrepresentation of the five major racial groups captured in the U.S. census, which includes Black, Latinx and white as well as Asian and Native American and Alaska native populations.

Why is inclusivity lacking?
One reason this may be happening is most scientific journals don’t require scientists to report study data by race and ethnicity, Steinberg said. Clinicaltrials.gov highly recommends it. Only recently, two of the top OB-GYN journals—Obstetrics and Gynecology and The American Journal of Obstetrics and Gynecology—have started requiring the reporting of racial and ethnic data.

Another factor, Steinberg said, could be access to academic medical centers. Medical care in the U.S. is segregated by insurance coverage, income and zip code which, due to systemic racism, intersect with race. Many OB-GYN patients cannot receive care at physicians’ offices that offer clinical trials. Furthermore, research eligibility criteria frequently excludes people with comorbidities that disproportionately impact people of color such as diabetes and heart disease.

“Since we know that race and health are intertwined, if you exclude certain co-morbidities, you’re more likely to exclude certain racial and ethnic populations,” Steinberg said.

Another possible reason, Steinberg said, is because of the United States’ history of “horrific” racist practices in research (e.g. the Syphilis Study at Tuskegee) that have led to a distrust of the U.S. medical system.

“The history should remain relevant as important context for social justice and the need for research reparations that acknowledge the horrific role doctors played in the abuse of non-white individuals,” Steinberg said. “However, several studies have actually demonstrated that initial willingness to participate in clinical trials does not vary by race/ethnicity.

“Publications in fact suggest that researchers, likely because of their projection of mistrust and negative stereotyping, seek participation of racially minoritized groups less often, further decreasing diversity in clinical trials. These factors are exacerbated by the homogenous predominantly white makeup of most researcher groups.”

Northwestern Medicine’s Dr. Lynn Yee is the study’s senior author. Other Northwestern study authors include Dr. Anna Marie Young, Dr. Connie Lu, Dr. Tierney Wolgemuth, Dr. Dario Roque, Julia D DiTosto, Kai Holder and Nora Laasiri.