In 2000, Marcia Killien and colleagues published “Involving Minority and Underrepresented Women in Clinical Trials: The National Centers of Excellence in Women’s Health,” hereafter “Involving Women,” in the Journal of Women’s Health and Gender-Based Medicine. Killien and colleagues address the historical exclusion of women from participation in medical research studies and difficulties in generalizing the results of studies that exclude women. They propose strategies to improve participation of minority and underrepresented women in clinical studies and identify systemic barriers such as mistrust, lack of access, and cultural insensitivity that have historically excluded those populations from clinical trials. The article emphasizes the necessity of inclusive research to ensure that medical advancements benefit all women equitably and suggests strategies to achieve more inclusive clinical research practices.
In 1994, researchers at the US National Institutes of Health, or NIH, started the Study of Women’s Health Across the Nation, or SWAN, to examine the bodily changes that occur in US women during middle age. Many of those changes are a result of menopause, which is the time twelve months after a female has had their last menstrual period. In the late 1990s, menopause was under-researched, and studies that did exist were based on participants who were not representative of the whole US population. SWAN investigators pushed for the inclusion of various racial and ethnic groups in their study to gain a broader understanding of menopause and aging. In particular, the researchers aimed to explore how symptoms of menopause differ among women, how those symptoms change over time, and how they can lead to certain health risks later in life. SWAN was among the first long-term studies to use a large, racially and ethnically diverse group of participants to study women’s transition into menopause and how it differs from chronological aging.
In 1935, US-based physicians Irving Freiler Stein and Michael Leo Leventhal published “Amenorrhea Associated with Bilateral Polycystic Ovaries,” hereafter “Amenorrhea,” in the American Journal of Obstetrics and Gynecology based on their clinical experience with seven female patients. In their article, Stein and Leventhal report finding a correlation between a lack of menstruation for a prolonged period, or amenorrhea, in the women and the presence of bilateral polycystic ovaries, in which cysts form in both ovaries. Stein and Leventhal theorize that such cysts form due to hormonal imbalances, which makes their presence indicative of an endocrine, or hormonal, disorder. That explanation contested a widely held belief at the time that inflammation caused amenorrhea. “Amenorrhea” was one of the first publications to propose a hormonal explanation for bilateral polycystic ovaries and to describe the cluster of symptoms that became the basis for diagnosing what later became known as polycystic ovarian syndrome, or PCOS, an endocrine disorder that affects five to eleven percent of women globally per year.