Historically, women have been excluded from clinical research, often sidelined due to concerns about hormonal fluctuations, reproductive health risks, and the potential complications of pregnancy. While these concerns may have been valid decades ago, they no longer hold up against modern scientific advancements and ethical standards. The exclusion of women from research has created significant gaps in medical knowledge, leading to treatments that inadequately address their unique biological and physiological needs. Today, there is no excuse for not including women in research studies—it is both a scientific necessity and an ethical imperative.
A Mandate for Inclusion
The NIH Revitalization Act of 1993 was a landmark moment in addressing the historical underrepresentation of women in clinical research. This legislation requires federally funded studies to include women and minorities, recognizing the importance of research that reflects the diversity of the population it serves (NIH.gov). Despite this mandate, challenges persist in achieving true equity in study designs and participant selection.
Including women in research is critical because biological differences between the sexes significantly affect disease progression, treatment efficacy, and health outcomes. For instance, cardiovascular disease—long considered a “man’s disease”—presents differently in women, often leading to misdiagnoses and delayed treatment. Without inclusive research, such disparities remain unaddressed, leaving women at a disadvantage in healthcare (American HeartAssociation).
Advances in Research Design
Modern research methodologies eliminate the once-cited challenges of including women in studies. Hormonal fluctuations, pregnancy risks, and sex-based variables can now be accounted for through advanced statistical tools, subgroup analyses, and innovative study designs. The ability to capture and analyze sex-specific data ensures that clinical trials produce results applicable to both women and men.
By including women, researchers gain insights that improve outcomes for everyone. Women make up nearly half of the global population, and their inclusion ensures a more comprehensive understanding of diseases and treatments. For example, sex differences in drug metabolism have led to discoveries about dosage adjustments needed for women, a finding that benefits all patients by improving precision medicine (FDA.gov).
Ethical and Scientific Responsibility
The exclusion of women from clinical research perpetuates gender inequity in healthcare, resulting in treatments that fail to meet their needs. It is not just a scientific oversight but an ethical failing. Addressing this bias requires a commitment to ensuring women are adequately represented in studies, particularly in areas where they have been historically overlooked, such as cardiovascular health, autoimmune disorders, and menopause.
Moreover, the broader impact of inclusivity in research cannot be overstated. By designing studies that reflect real-world populations, the medical community not only ensures better care for women but also enhances outcomes for everyone. Treatments developed with a full understanding of sex-based differences improve the safety and efficacy of healthcare globally.
Moving Forward
While progress has been made since the NIH Revitalization Act, there is still work to be done. Women remain underrepresented in many areas of research, and diseases disproportionately affecting them continue to receive less funding and attention. Advocates for women’s health must push for continued enforcement of inclusion mandates, increased funding for female-focused research, and greater awareness of the importance of sex-specific medical insights.
There is no longer an excuse to exclude women from research studies. It is both a scientific necessity and a moral obligation to ensure that healthcare is equitable, effective, and inclusive. By prioritizing the inclusion of women in research, we can close gaps in medical knowledge, improve outcomes, and create a healthier future for all.
By Dr. Mia Chorney
DNP, FNP-BC, MSCP
Co-Founder, and CMO of The Pause Technologies