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Breaking Down Barriers: Women and Clinical Trials

Feb 23, 2018 11:28PM ● By Alyssa McGinnis

The women’s movement of the 1970s brought issues such as pay equity, birth control, and 

gender roles into the national spotlight. But it would be another 20 years before policies regarding women in drug trials would get a much-needed makeover.

In 1977, the FDA specifically recommended against including women of childbearing age in Phase I and early Phase II drug trials. Lora Black, RN, MPH, Senior Director of Clinical Research at Sanford Research says this broad policy was damaging, not just from an equity standpoint, but from a scientific standpoint.

“It’s not just about equal representation,” says Black, who is also a clinical instructor with the USD Sanford School of Medicine. “Men and women differ at the cellular level. Women have different organs and different hormones. Sometimes even cycles can affect medications and dosages, etc.”

A case in point is the insomnia drug zolpidem (Ambien). In 2013, new data suggested the women may metabolize the drug differently than men, potentially resulting in pronounced next-morning impairment at the recommended dose. In light of the new data, the FDA recommended that the zolpidem dose be cut in half for female patients.

“Some drugs stay in the system longer if you have more body fat and women have more body fat than men,” says Black. “So body composition can also play a role.”

Although the NIH established a policy recommending that researchers include women in studies in 1989, it was not until 1993 that Congress made it a law. Today, NIH will not fund any grant or support any project that does not agree to include a gender breakdown in animal trials and report on the sex, race, and ethnicity of the people enrolled in clinical trials.

“Different ethnic groups potentially have different DNA, which can affect how they are going to respond to medication,” says Black. “Those are things we can’t capture unless they are included in clinical trials.”

Black says the challenge now is to make sure providers offer clinical trials to their eligible female patients and ethnic minority patients and to encourage patients to enroll.

“So, it is a multifaceted education piece,” says Black. “We need folks to understand that, without engaged volunteers, we can’t move the science forward. So we are always trying to find different ways to get that message out to patients, researchers, providers, and collaborators, such as device manufacturers.”

“We want to make sure that, when we are designing clinical trials, we are designing them with differences in mind, so that we make sure we are answering the right questions.”

Web Extras: 

Find out more about the history of women in clinical researcher from the Office of Research on Women’s Health

Sanford researchers received national recognition this fall