Until 1993, no regulations were in place to ensure that women were part of research studies and clinical trials. This meant that sex and gender-based differences were not considered during the development of treatment options for many diseases and health conditions.
This systematic exclusion of a population from medical research represents a significant blind spot in modern healthcare. Population health involves understanding and addressing the diverse factors that influence health outcomes across different populations. But until 1993, women who account for half the world’s population, and over half of the United States population, were not considered.
Many diseases disproportionately affect women, yet there are gender gaps in research and care. Despite making up nearly two-thirds of Alzheimer's patients, only 12% of Alzheimer's research focuses on women. Another study found that women are often overmedicated because drug dosage trials are done on men.
In a recent publication, “The Continued Invisibility of Women in Population Health” in JAMA Health Forum, Teri L. Hernandez, PhD, RN, from the University of Colorado Anschutz College of Nursing and Rosa M. Gonzalez-Guarda, PhD, MPH, RN, from the Duke University School of Nursing, highlight the important role of women in improving population health and the need to support ongoing women’s health research.
Gender Influences on Population Health
According to the article, women’s health research has generated evidence to support better clinical care for women and has more broadly improved population health. Yet women’s health has been an area of focus only recently, and significant gaps remain in the understanding of sex and gender-based differences within the scope of disease prevalence and impact. The authors argue the importance of continued support for women’s health research as a central strategy to promote overall population health.
“The optimal health and well-being of women are cornerstones to achieving improved population health,” says Dr. Hernandez and Dr. Gonzalez-Guarda in the article.
Despite overwhelming research that supports that sex and gender-based factors influence on overall health outcomes, women’s health has historically been invisible.
A History of Women in Clinical Trials and Research
Women are often underrepresented in health research due to historical policies and persistent barriers. Many clinical guidelines in use today are based on data from trials that included mostly older white males.
In 1977, a Food and Drug Administration policy recommended excluding women of childbearing potential from phase I and early phase II drug trials. This policy resulted in researchers adopting a cautious approach to female participation in all clinical trials and research. The rationale was that participation in research had increased risks for women.
In 1993, federal policies mandated the inclusion of women in clinical trials conducted by the National Institutes of Health (NIH). But the exclusion of women for so many years resulted in substantial gaps in health care.
One example of this gap is how disproportionately heart disease affects women. Women are more likely to die after a heart attack than men. Heart attack symptoms also differ between men and women. Standard treatments were designed with men in mind, and unsurprisingly, women are more likely than men to have adverse cardiovascular events after the placement of a stent.
Another study concluded that gender disparity exists in the use of implantable devices that are surgically placed in the chest for men and women with chronic heart failure. Smaller women have limited access to the left ventricular assist device (LVAD) because these devices require a minimum body surface to fit properly.
Diverse Women in Research Studies
While there has been some improvement in the representation of women in research, there is still limited representation from racial and ethnic minoritized groups. Certain ethnic groups face higher risks for different diseases due to genetic, socioeconomic, and environmental factors.
The article states that the path forward “requires addressing barriers to the engagement of diverse groups of women in research and investing in strategies developed for women that ensure that racial and ethnic minorities and sexual and gender minorities are not excluded.”
Interventions to improve women’s health in the United States should evolve based on lessons learned from policies and practices implemented in other countries that have improved women’s health.
Visible Investment in Women’s Health
The authors propose that intentional efforts are needed to ensure a continued and visible investment in women’s health research and practice that is informed by women.
In Northern Ireland, the group Nothing About Us without Us is collecting data from women via online questionnaires about their health. The grassroots organization aims to gather and record experiences of local women regarding their health care to then influence funding for a better women’s health strategy in their country.
Another step that can be taken is to ensure more women pursue careers in science. The United Nations International Day of Women and Girls in Science aims to involve women in science. Encouraging women to participate in science and research will improve gender disparities in clinical trials and research studies.
The Way Forward
Global efforts, organizations, and government officials should continue to invest in and support women’s health research. Research studies should consider the biological, psychological, social, and environmental factors that shape health among women. Dr. Hernandez and Dr. Gonzalez-Guarda conclude that “women’s health is not an ideology but rather is based on decades of biomedical, social, and health services science and experience that underscore the unique conditions influencing health in this population.”
Additional rules and regulations should be put in place to ensure clinical trials and research studies include women from a variety of ethnicities and backgrounds. Women can also be proactive in creating health equity by asking their providers about participating in medical research or ongoing clinical trials.
By addressing barriers, engaging a variety of groups of women in research, and supporting research in women’s health, research can be used to inform clinical guidelines and population health efforts to provide better health care to the entire population.
