Despite the challenges, clinical research must include women of reproductive age

Despite the challenges, clinical research must include women of reproductive age

HealthyWomen hosted a congressional briefing, “Women in Clinical Trials: The Research Challenge During the Reproductive Years,” on June 1, 2023.

Clinical trials have long focused on white men, leaving women woefully underrepresented. The lack of diversity in clinical trials means that healthcare professionals (HCPs) often lack enough data on how certain conditions affect women or which treatments work – and at what dose – for women.

These knowledge gaps are particularly evident for pregnant and breastfeeding 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 addressing the challenges of including women of reproductive 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) in the office of Women’s Health and current board member of HealthyWomen. Speakers included experts representing healthcare professionals, researchers and patient advocates.

Action in Washington, DC

The event began with taped remarks from Florida Representative Lois Frankel. Almost 4 million women give birth in the United States every year, and Frankel noted that everyone deserves to be safe and healthy while pregnant and as a new mother.

But pregnant and breastfeeding women are often not sure which drugs and medical devices are safe to use. This leads many to give up breastfeeding or avoid taking medications, decisions that can be harmful and even dangerous.

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

In 2016, Congress established the Task Force on Research Specific to Pregnant and Lactating Women (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 lactating women in clinical research. Frankel and a bipartisan group of lawmakers secured funding for an advisory committee to oversee implementation of the recommendations.

“Our mantra is to protect pregnant people through research instead of research,” said Diana Bianchi, MD, director of the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD) from the National Institutes of Health and chair of PRGLAC.

To illustrate how NICHD funding is being used to implement PRGLAC recommendations, Bianchi described a study showing that several commonly used drugs breastfeeding women take in infants at very low levels. Initial 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 Medicinerepresented the point of view of health professionals specialized in the care of pregnant women, especially those at high risk of pregnancy-related complications.

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

A common thread among these groups is the need for medications, Abbott said. Indeed, 9 out of 10 women report having taken some kind of medicine during pregnancy e 7 out of 10 take at least one prescription drug. However, she said, little is known about how safe or effective most drugs are in pregnant women because pregnant and breastfeeding women are systematically excluded from most clinical research to protect them and their babies.

While Abbott said these healthcare professionals are used to practicing medicine with imperfect information, that doesn’t mean it’s the best way to practice. For example, you mentioned that women often stop taking antidepressants while pregnant or breastfeeding because of safety concerns. But skipping those meds can be dangerous; A CDC analysis showed that mental health conditions are the leading cause of death during and after pregnancy.

“Our inability 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 Shades of Blue projectan organization dedicated to helping black women before, during and after childbirth.

To make positive change, however, Matthews advocated listening to community voices and addressing barriers to clinical research engagement, especially in communities of color.

Barriers include a lack of awareness of the availability of clinical trials and a lack of trust stemming from the historical trauma that people of color have experienced at the hands of the scientific and medical communities.

“If you don’t appreciate the fact that there’s historical trauma associated with a lot of what’s happening, then you’re missing the point,” Matthews said. “You will never get the results or the best results you want if you don’t listen to the stories of people with lived experience.”

This investment in improving engagement is essential, Matthews said. You advocated patient engagement with compassion, intentionality, clear understanding, and respect.

“It doesn’t matter how you see us – the community, the customer or the consumer – we are the most important 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.”

Move past 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, who require special protections. In June 1993, the FDA rescinded a 1970s policy that barred most women of reproductive age from participating in clinical research. In 2016, the FDA launched the Diverse Women Initiative in Clinical Trials increase the participation of women in clinical trials.

From half of clinical trial participants are now women, but trials have yet to include a broader representation of women of 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 to increase research participation among a wider cross section of people. By making participation more local and more convenient, a wider range of people will have access to education about clinical trials and be empowered to decide whether 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, non-profits, businesses and the research community – to ensure adequate representation.”