Ohio State University: Pregnant women should have a say in designing clinical trials, anthropologist says

Making diversity a priority in clinical trials that involve pregnant populations is an important goal, but addressing the systemic barriers that participants face is necessary to reduce racial and economic disparities, says Wellesley College anthropologist and author Natali Valdez.

Natali Valdez
“Diversity and inclusion efforts do not directly address long-term exposure to unequal and unhealthy living conditions,” Valdez said during a Dec. 6 visit to visit to The Ohio State University. “Including more diverse people in clinical research is no doubt a worthy and necessary cause, but I argue that to address issues of equity as distinct from diversity requires much better analysis.”

During her talk, presented by Ohio State’s Department of Anthropology, Valdez shared findings outlined in her new book, “Weighing the Future: Race, Science and Pregnancy Trials in the Postgenomic Era.” In her research, Valdez said she studied hundreds of clinical trials involving expectant mothers across the United States and the United Kingdom over the course of three years.

“I interviewed scientists and staff, I learned about their methods and procedures in implementing clinical trials and I participated as a staff member on one of the trials,” she said.

Valdez said her research found that clinical trials often fall short when not factoring in issues faced by participants of color and those from lower income levels. Those issues include housing instability, difficulty accessing prenatal care, and the disproportionate rates of premature birth and maternal and infant mortality among Black women.

“Black women in the United States have two to three times the rate of premature birth and maternal mortality compared to white women” for reasons that have not yet been fully determined by the medical community, Valdez said. “The U.S. racial disparity in premature birth and death has not changed in the past 60 years, and some trace this disparity back further to slavery.”

Racial disparities among pregnant populations also exist in the United Kingdom, Valdez said.

“Black women in the United Kingdom have a much higher chance of maternal mortality and pregnancy complications than white British women,” she said. “In addition, both the U.S. and U.K. have similar rates of obesity during pregnancy.”

To discourage a pregnant woman from gaining too much weight, a clinician may have good intentions when suggesting that a trial participant should snack on an apple instead of a candy bar and wear a pedometer to track her daily steps, Valdez said. Her research, however, determined that the root causes of obesity during pregnancy and gestational diabetes are far more complex.

“We already have a strong indicator for gestational diabetes, and it actually is homelessness or houseless-ness. Pregnant people who are houseless or have unstable housing have higher rates of (gestational diabetes), but that’s rarely studied in a clinical trial,” she said. “And there are such few forms of evidence-based methods for saying, ‘Instead of investing $10 million to $7 million into the clinical trials, we might be able to invest in providing stable housing for pregnant people, and that might have a better impact on avoiding gestational diabetes.’”

Programs like Ohio State Wexner Medical Center’s Moms2B aim to reduce racial and economic disparities among expectant mothers in Columbus by providing them and their families with food, education and support. Such programs advance a theory that is gaining traction that pregnant populations shouldn’t be solely responsible for fetal health, and that environmental and societal factors also play a significant role, Valdez said.

“We all contribute to the social, institutional and environmental circumstances that shape each pregnancy, birth and child,” she said. “Framing the maternal environment as only pregnant bodies and behaviors rather than understanding that it is everything that could influence a growing fetus like systems of poverty and racism entails social and material consequences for everyone – and particularly, vulnerable populations.”

Valdez said her research indicates that one strategy that could make a major impact in improving the health of expectant mothers is including them in the design of the very clinical trials that aim to help them.

“It’s the process that might generate different outcomes,” Valdez said, “so that people who are targeted for interventions get to make the decision about what those interventions are.”