Promoting the Inclusion of Women in Clinical Trials

Women were historically excluded and continue to be underrepresented as participants in medical research. Yet sex differences (based on biological factors) and gender differences (associated with behavior, lifestyle, and life experiences) impact myriad aspects of health, from being diagnosed with any given medical condition, to disease presentation and progression, and response to treatments and interventions.

The findings from medical research that included only men may not apply to women. It is crucial to address the resulting gaps in our understanding of women’s health if we are to improve women’s health outcomes.
 

How Including Women in Clinical Trials Can Improve Outcomes

“Without looking at women across different populations and throughout their lifespans in research, women and their care will always be left behind,” said Kathryn Schubert, CEO and President of The Society for Women’s Health Research (SWHR). “Our mission at SWHR is to promote research on biological sex differences in disease and improve women’s health through science, policy, and education. Our vision is to make women’s health mainstream. Including women in trials is paramount to achieving all of these goals,” she continued. “We cannot expect women and their healthcare providers to be able to make the best healthcare decisions if they are given only limited or incomplete information.”

SWHR works to raise awareness of the importance of women’s health at the national policy level and advocates for research organizations to be more inclusive of women in clinical trials. SWHR also helped establish the NIH Office of Research on Women’s Health (ORWH) in 1990 and was instrumental in the passage of the NIH Revitalization Act of 1993, which mandates that all NIH-funded clinical research includes women and minorities.
 

What Happens When Women Are Excluded from Clinical Trials?

Women who are pregnant or breastfeeding are often excluded from clinical trials. The downside of this abundance of caution means that many treatments are not studied for safety during pregnancy. This leaves many women of childbearing age who take medications or need treatment for a variety of chronic illnesses with incomplete information to guide their choices.
 

Including Women in Clinical Trials Across Their Lifespan

SWHR addresses women’s health needs across the age spectrum. Among its many efforts, SWHR is addressing research gaps for older women through its Alzheimer’s disease (AD) program. Two-thirds of people in the U.S. who have Alzheimer’s disease are women, and SWHR is working with experts in the field to understand how to better integrate women and populations who have been historically marginalized into AD research.

SWHR also recently launched its Women’s Health Equity Initiative, highlighting data on women’s health in the U.S. and encouraging the identification and implementation of solutions to improve health equity between men and women across diseases, conditions, and life stages.

In addition, SWHR is in the process of building a women’s health dashboard based on data from the National Institutes of Health, U.S. Food and Drug Administration, Centers for Disease Control and Prevention, industry, and publishers. It will measure progress in inclusion based on data points such as morbidity and mortality rates, insurance coverage, and federal research investments.
 

Broadening the Scope of “Women’s Health”

While SWHR focuses on broader policy change and initiatives, Women’s Health Research at Yale (WHRY) is changing the conversation. It is broadening the scope of what is considered women’s health and taking deep dives into what is studied—from human biology at the cellular level to the social experiences that affect our health.

WHRY has funded more than 100 new research studies over the past two decades, through a pilot program that provides seed grants to investigators on the Yale faculty, to ensure more inclusive research is under way. These grants focus on conditions that have high morbidity or mortality for women, according to Carolyn M. Mazure, Ph.D., Spungen Bildner Professor in Women’s Health Research, Professor of Psychiatry and Psychology, and Director of WHRY. The initial data they gather typically paint a compelling enough picture to attract additional funding to expand these efforts and build enduring research programs.

“We study conditions women experience, from cardiovascular disease to cancers, and our focus is generating practical benefit from our studies. Whether we are studying genes or psychological stress, we are always focused on what the data can tell us to improve human health,” she said.
 

Training Medical Professionals and the Public to Recognize Sex and Gender Differences in Health

WHRY also works with medical school course directors to incorporate data on gender and sex differences in health into curriculum, so that the next generation of medical practitioners and scientists bring this perspective into their practice and research.  Woven into these discussions is the importance of including women as participants in medical research.

WHRY helps educate the public about the influence sex and gender can have on health. Cardiovascular disease (CVD) is an important example. Heart attacks often present differently in men and women: Men having a heart attack are more likely to experience chest and left arm pain, while women may feel shortness of breath, pain in the jaw or shoulder, extreme tiredness, and heartburn. Both the public and health professionals may be less aware of heart attack symptoms in women, which may cause them to be overlooked. As captured in a study published in the European Heart Journal Acute Cardiovascular Care, when both sexes presented with possible heart attack symptoms, clinicians were more likely to consider the diagnosis of acute coronary syndrome in men (44.5%) than in women (39%).

A recent, not-yet-published WHRY study offers an important new vision for diagnosis and treatment of heart attack. This study seeks to transform the diagnosis for women by recognizing that standard testing cannot detect small blood vessel spasms, a type of heart attack suffered in greater numbers by women. This study employs a technique for those with symptoms of a heart attack that tests for small vessel disease if coronary obstruction is not found and, as importantly, is using this method now in patient care.

Understanding how biological and social differences affect women is essential to improving health outcomes. Including adequate numbers of women in clinical trials is a critical first step.