Closing the gender bias in clinical research

Gender bias in clinical research is nothing new. Females have been excluded from centuries of medical research which has meant that even today, women’s diseases are often missed, misdiagnosed, or remain unknown.?

In recent years, the medical community has made significant strides in understanding and addressing gender bias in clinical research. However, there is still a lot of work to be done.

The historical context of gender bias in clinical research

Historically, medical research has predominantly focused on male subjects, leading to a significant gap in knowledge regarding how women respond to various treatments. Today, this is what we refer to as the ‘gender data gap’ – highlighting the fact that the majority of data across society is based on the male body and experiences.?

From the earliest days of medicine, women were considered to be inferior to men with the Greek philosopher Aristotle describing women’s bodies as ‘mutilated bodies’ in On the Generation of Animals. These ideas influenced the Western medical mindset and resulted in women often being excluded from trials, thus putting women’s health at risk. For too long, it was falsely assumed that processes underpinning disease, disease symptoms, and the way drugs work in the body were the same for both male and female bodies.

A tragic example of clinical gender bias is the Thalidomide affair, which took place in the early 1960s. Thalidomide, a drug prescribed to pregnant women to alleviate morning sickness, caused numerous birth defects. This devastating incident led to a drastic decline in female participants in clinical trials. The US Food and Drug Administration recommended excluding women of childbearing potential from drug trials, a practice that persisted for decades until it was reversed in the 1990s.

In the modern day, scientist know that female bodies are genetically different and as GSK highlights: “they experience differences in the prevalence, course?and severity of many common human diseases?and metabolize foreign substances – like medicines and vaccines – differently.”

Yet until very recently, clinical research was plagued by a total lack of diversity resulting in life threatening consequences.

Efforts to address gender bias

In the past two decades, several key initiatives and regulatory changes have been implemented to address the gender data gap:

·?????Regulatory changes: In 1993, the U.S. National Institutes of Health (NIH) Revitalization Act mandated the inclusion of women and minorities in NIH-funded clinical research. This was a significant step towards ensuring that clinical trials are more representative of the population as a whole. The NIH also established guidelines requiring researchers to analyze and report data by gender, which has helped to highlight differences in treatment outcomes between men and women.

·?????Pharmaceutical industry initiatives: The pharmaceutical industry has also taken steps to address gender bias in clinical research. Many companies now have policies in place to ensure that their clinical trials include a diverse population of participants, including women of childbearing age, older women, and women from different ethnic and socioeconomic backgrounds. Some companies have also established women’s health research units to specifically focus on the unique health needs of women.

·?????Educational initiatives: Education and training programs for researchers and healthcare professionals are also critical to addressing gender bias in clinical research. Many medical schools and research institutions now offer courses and training programs on gender differences in health and the importance of including women in clinical research. These programs help to raise awareness of the issue and provide researchers with the knowledge and skills they need to conduct more inclusive research.

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Indicators of ongoing gender bias

Examples highlighting the persistence of gender bias:

Scientific studies: The Medical Research Foundation quoted a study that reveals that less than half of scientific research reports the sex of cells. When sex is noted, male cells are predominantly used, leading to results often inaccurately generalized to female cells, which may react differently.

Medical textbooks: A 2008 study of textbooks from 20 prestigious universities found that images of heterosexual white male bodies appeared three times more often than those of women to illustrate neutral body parts. This, along with the insufficient inclusion of female participants in clinical research, has resulted in significant gaps in sex-specific data, endangering millions of women.

FDA intervention: In 2013, the US Food and Drug Administration (FDA) had to adjust the dosage recommendations for the sleeping medication zolpidem for women. The previous guidelines, based on male physiology, compromised alertness and increased the risk of accidents, especially during morning commutes.

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Strategies for closing the gender gap in clinical research

The following strategies can help to further close the gender gap and ensure that clinical research is more inclusive and representative:

Increasing female participation: One of the most effective ways to address gender bias in clinical research is to increase the participation of women in clinical trials. This can be achieved by designing trials that are more accessible and appealing to women, such as offering flexible scheduling, providing childcare, and ensuring that study materials are written in plain language that is easy to understand.

Promoting gender-sensitive research design: Researchers should consider gender differences when designing their studies, including factors such as hormonal variations, differences in body composition, and gender-specific risk factors for disease. This can help to ensure that the results of the study are more relevant and applicable to both men and women.

Analyzing data by gender: It is important for researchers to analyze and report their data by gender to identify any differences in treatment outcomes between men and women. This can help to highlight areas where further research is needed and ensure that treatment protocols are more effective for both genders.

Machine learning: Machine learning is being used to address gender bias in clinical trials by analyzing and correcting imbalances in data. Researchers have developed algorithms that evaluate gender representation in studies, enabling more accurate and gender-sensitive predictions, which improve the quality of treatments for both women and men.

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Conclusion

Closing the gender bias in clinical research is not just a matter of fairness; it is a critical step toward improving health outcomes for women and ensuring that medical treatments are safe and effective for everyone.

?The journey to closing the gender gap in clinical research is ongoing, but with continued effort and commitment, we can build a healthcare system that is truly equitable and just. Let us seize this opportunity to make a difference and ensure that all individuals, regardless of gender, have access to the highest quality care and treatment.

Ready to change the narrative on gender bias in clinical research?

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