Women's Health

Despite challenges, clinical research must include women of childbearing age



HealthyWomen hosted a Congressional Briefing, “Women in Clinical Trials: The Challenge of Research in the Childbearing Years,” June 1, 2023.

Clinical trials have long focused on white men, leaving women woefully underrepresented. The lack of diversity in clinical trials means healthcare providers (HCPs) often don’t have enough data about how certain conditions affect women or what treatments work – and at what dose – for them. women.

These knowledge gaps are particularly marked for pregnant and lactating women. That’s a problem, according to Beth Battaglino, RN-C, CEO of HealthyWomen.

“Pregnant women get sick and sick women get pregnant,” Battaglino said during a congressional briefing on the challenges of including women of childbearing age in clinical trials.

The briefing, Women in Clinical Trials: The Challenge of Research during the Reproductive Years, took place on June 1, 2023 and was moderated by Marsha Henderson, former Associate Commissioner for Women’s Health at the Food and Drug Administration (FDA) at Bureau of Women’s Health and current board member of HealthyWomen. Panelists included experts representing healthcare professionals, researchers and patient advocates.

Action in Washington, D.C.

The event kicked off with remarks recorded by Rep. Lois Frankel of Florida. Nearly 4 million women give birth in the United States each year, and Frankel noted that everyone deserves to be safe and healthy during pregnancy and as new mothers.

But pregnant and breastfeeding women often do not know which drugs and medical devices can be used safely. This leads many to give up breastfeeding or avoid taking medication, decisions that can be harmful or even dangerous.

“We can and must do much better for pregnant and breastfeeding women,” Frankel said.

In 2016, Congress established the Pregnant and Nursing Women Specific Research Task Force (PRGLAC) as part of the 21st Century Cures Act.

In 2018, PRGLAC presented a report to Congress that included 15 recommendations to promote the inclusion of pregnant and breastfeeding women in clinical research. Frankel and a bipartisan group of lawmakers won funding for an advisory committee to oversee implementation of the recommendations.

“Our mantra is to protect pregnant women through research rather than research,” Diana Bianchi, MD, director of the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD) told the National Institutes of Health. and President of PRGLAC.

To illustrate how NICHD funding is used to implement PRGLAC recommendations, Bianchi described a study showing that several drugs commonly used by breastfeeding women appear in babies at very low levels. Early results suggest that these drugs may be safe for breastfeeding women and their babies.

The view from the doctor’s office

Rebecca Abbott, senior director of advocacy for the Society for Maternal-Fetal Medicine, represented the perspective of healthcare professionals who specialize in caring for pregnant women, especially those at high risk for pregnancy-related complications.

One in five women of childbearing age in the United States has two or more chronic conditions, putting them at higher risk for pregnancy complications. Other women develop conditions during pregnancy, such as dangerously high blood pressure.

A common thread between these groups is the need for medication, Abbott said. In fact, 9 out of 10 women report taking medication during pregnancy and 7 out of 10 take at least one prescription medication. However, she says, little is known about the safety or effectiveness of most drugs in pregnant women, because pregnant and breastfeeding women are routinely excluded from most clinical research to protect them and themselves. their babies.

Although Abbott said these medical professionals are used to practicing medicine with imperfect information, that doesn’t mean it’s the best way to practice. For example, she said women often stop taking antidepressants during pregnancy or while breastfeeding for safety reasons. But skipping these drugs can be dangerous; a CDC analysis showed that mental health issues are the leading cause of death during and after pregnancy.

“Our failure to gather the necessary safety and efficacy data creates situations where patients and clinicians make decisions based on unknown or perceived harms rather than clear and robust safety data,” Abbott said.

Respect the voices of the community

“We have the power to change the past,” said Kay Matthews, founder of the Shades of Blue Project, an organization dedicated to helping women of color before, during and after childbirth.

To effect positive change, however, Matthews advocated for listening to community voices and breaking down barriers to engagement in clinical research, especially in communities of color.

Barriers include lack of awareness of the availability of clinical trials as well as lack of trust resulting from the historic trauma that people of color have suffered at the hands of the scientific and medical communities.

“If you don’t value the fact that there’s historical trauma associated with a lot of what’s going on, then you miss the mark,” Matthews said. “You’ll never get the results or better results you want if you don’t listen to stories from people with lived experience.”

This investment in improving engagement is critical, argued Matthews. She advocated for patient engagement with compassion, intentionality, clear understanding and respect.

“However you see us – the community, the customer or the consumer, we are the biggest part of that,” Matthews said. “We must first build trust within our communities of color before we can truly make a lasting impact for change.”

go beyond history

According to Ramita Tanden, head of clinical trials at Walgreens, concerns about the mistreatment of pregnant women have led to research guidelines that designate pregnant women as vulnerable people, requiring special protections. In June 1993, the FDA rescinded a 1970s policy that prohibited most women of childbearing age from participating in clinical research. In 2016, the FDA launched the Diverse Women in Clinical Trials Initiative to increase women’s participation in clinical trials.

About half of clinical trial participants are now women, but trials have yet to include a broader representation of women from diverse backgrounds, including race, ethnicity, sexual orientation, age, disability and health status, Tanden said.

Tanden argued that community pharmacies can be a welcoming entry point for increasing research participation among a wider range of people. By making participation more local and convenient, a wider range of people will have access to clinical trial education and be empowered to decide whether or not to participate. If they choose to participate, it will be easier to do so.

Battaglino concluded the event with a call to collaborative action. “Clearly it will take all of us – government, nonprofits, business and the research community – to ensure appropriate representation.”



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