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February 19, 2024

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Increasing Women in Science—as Clinical Research Leaders and Participants

MVP-INSIGHTS_ARTICLE-Increasing Women in Science

Overview

Clinical trials leave pregnant women on the sidelines. Infectious disease physician and leading vaccine developer Judith Absalon, MD, MPH, FIDSA, offers insight into issues around women in science.

What happens is then you don't have clinical trial data about pregnant women?

Drug and vaccine developers have devoted much recent effort to increasing the diversity of people who participate in clinical trials. These efforts have paid off, at least in gender parity. Today, most clinical trials in the United States come close to enrolling equal numbers of men and women.

But enrolling pregnant women remains a hurdle. Companies and investors shy away from studies in pregnant women for fear of harm to both the women and their babies.

“While that’s understandable,” said Judith Absalon, MD, MPH, FIDSA, “what happens is then you don't have data about pregnant women. We see what happens when things are used after approval, which is not ideal.” Absalom, an infectious disease physician and leading vaccine developer, is today Vice President and Clinical Sciences Disease Area Lead of Infectious Diseases & Virology at GSK.

“My first trial was an HIV clinical trial of an old drug in pregnant women. It was one of the first to have data in pregnant women,” said Absalon. She also worked on a vaccine for Group B strep, a bacterial infection that pregnant women can sometimes transmit during delivery, with devastating impact to their babies.

Development of COVID vaccines brought the issue of pregnant women in clinical trials to the forefront again, notes Absalon, who was a core member of the Pfizer team that worked on the mRNA COVID-19 vaccine. “None of the companies included pregnant women in those clinical trials. There was concern about that. Various companies started work looking at COVID vaccines and pregnant women, but then it became an ethical issue because this was a pandemic at the point at which there was an intervention that really could save people's lives. They couldn't continue some of the studies.”

Going forward in vaccine development, Absalon supports including pregnant women in trials up front. “It should be men, women and pregnant women. Everybody in a Phase 3 clinical trial wants to know that a product is safe. It’s an important area of discussion right now.”

Filing the Female STEM Professional Pipeline

Absalon also acknowledges the importance of boosting the numbers of female professionals in science—of filling and maintaining a pipeline of women in STEM careers. “It's something that I try to do individually. I spend time when I can talking to high school students, mentoring more junior colleagues.”

As for herself, Absalon says, “No one needed to tell me because it didn’t occur to me that I couldn’t be a physician. It didn’t occur to me that I couldn’t major in math.” Her parents immigrated from Haiti to Brooklyn, NY, where she was born, and her father was an OB-GYN. “I’m not the first physician in my family, so that wasn’t new. I always wanted to be a doctor.”

“I appreciate the fact that there are very few people that look like me and do what I do. Part of it is just telling people how I got here, which is not quite direct. I always tell people your path doesn’t need to be straight. So, I share my experiences. I think all of us women in STEM just need to be open, do more of that. It seems like very little, but I think it does have a huge impact.”

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