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With March being Women’s History Month, we remember that women have historically been marginalized in areas such as clinical trials, and how important it is to work towards women’s empowerment. Activists like Margaret Sanger, who popularized the term birth control, and Katherine McCormick, who Sanger convinced to fund the development of “the pill,” led major initiatives that transformed society and gender relations in the earlier half of the 20th century. Appreciating the accomplishments of inspirational women leaders also demonstrates the importance of looking forward to future leaders to solve frighteningly similar issues of marginalization. The solution begins with acknowledging the lack of inclusivity toward diverse women from all over the world in clinical research data across the health sciences industries.

As modern medicine and technology have advanced, the scientific understanding of our genetic composition has become more astute. Projects like 23andMe and the Human Genome Project have furthered our understanding of the genomic composition of a grand diversity of human bodies. Human genetics are indeed extremely similar in that we are a definitively cohesive and singular human race around the world. Yet, humans also show distinct differences in medical profiles along demographic lines, leading to demographic-specific clinical trials.

As a unique trial group and a demographic that makes up half of the world’s population, women require specialized medical and care plans, just as anyone else does. Advancements in women’s health and care have been shown not only to improve  women’s quality of life but to better society as a whole. For example, the introduction of modern contraception allowed women to marry later and exercise greater choice over when or if they became pregnant. It also triggered a myriad of other improvements in reproductive health technology, as well as ripple effects like economic independence, which stimulated and enlarged the economy and ultimately led to improved opportunities for career choice and freedom. While the improvements that contraception introduced are undeniable, more is still needed in terms of women’s visibility in clinical research, including women from different ethnic and cultural backgrounds.

A recent FDA release showed the backgrounds of people participating in clinical trials for a set of 48 newly introduced drugs. Different drugs were tested on different proportions of demographic subgroups. 72% of the total number of trial patients were women, 72% of whom were White, 9% Black or African American, 9% Asian, and 18% Hispanic. These numbers are a step forward in transparency but reflect a heavy bias towards a single group, quite clearly being White women in this set of cases. In order to advance women and humanity toward a healthier world, the need for inclusivity in research for diseases that affect women of different backgrounds is paramount.

Despite improvements in women’s health, there are still significant gaps; a startling figure is that 78% of autoimmune disease patients are women. Genetic variation across clinical groups reminds us that catering to a patient-centric set of needs helps us both treat and cure women of diverse backgrounds, and also help shape a better society. Women’s empowerment extends beyond policy changes, and can be leveraged by safe, patient-centric medical innovations. New drugs meet urgent needs, but to be safely introduced they should be tested more inclusively, on people from all demographic groups.

Demographic-specific research is important as it helps understand, and then in turn treat, how specific underserved demographics are vulnerable to certain diseases. Type 2 Diabetes for example, afflicts African-Americans, Asian Americans and Hispanic/Latino-Americans at significantly higher rates than in Caucasian Americans. As a successful example of demographic-specific research, the Joslin Diabetes Center hosts its annual A Taste of Ginger event at the Museum of Fine Arts in Boston to raise funds for its Asian-American Diabetes Initiative, founded by Dr. George King. While this year’s event was cancelled due to COVID-19, donations are still being held through the Joslin Center’s website in order to help further research for the Asian American community. If you’re interested in showing your support, please visit the donations page.

In the end, everyone benefits from demographic-specific clinical research, as it allows for more effective, efficient treatment options and opens grand possibilities for social improvement. Everyone has the right to fair treatment, regardless of their specific demographic background. The FDA’s recent women-oriented report shows an impetus towards clinical trials including women, yet indicates there is room for expanding clinical trials to encompass more diverse populations. Inclusive testing allows medicine and care to reach a greater magnitude both domestically and around the world, inspiring us to push the reach of medical care.

  •   Dr. Hope

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