Uncovering gender bias in clinical trials: A call for inclusivity and precision

In the realm of life sciences and medical research, groundbreaking technologies are continuously emerging, promising transformative treatments and therapies. However, the effectiveness and safety of these advancements are deeply rooted in the foundation of clinical trials. 

These trials not only shape patient trust in medicine but also dictate the accessibility and inclusivity of new therapies. 

Yet, for decades, male bias in medical research has allowed the assumption that medical responses observed in the average white male would universally apply to all individuals to prevail, leading to significant gaps in health outcomes—particularly affecting women and minority groups.Our Head of Cell and Gene, Stuart Lowe, interviewed Diana Torgersen, Executive Director for External Innovation and Emerging Science at Organon, Shirin Heidari, Founding President of GENDRO, and Deana Mohr, CEO of Muvon Therapeutics as part of our podcast series Invent:Life Sciences. Stuart gets their expertise on the root cause of this issue, the consequences, and what scientific researchers can do to improve outcomes for marginalised groups in healthcare.

The assumption that medical responses observed in the average white male apply to all individuals has lead to significant gaps in health outcomes—particularly affecting women and minority groups.

The historical exclusion of women from clinical trials until the 1990s left a glaring blind spot in medical research. This exclusion was compounded by using animal models and cell cultures that did not accurately represent the diverse human population. 

The assumption that the male body was the standard for medical research further perpetuated this bias. Safety concerns related to pregnancy and hormonal variability in women contributed to this exclusion. It was not until as recently as 2016 that the National Institutes of Health (NIH) mandated the reporting of sex as a biological variable, marking a pivotal shift towards acquiring essential gender-specific data in medical research.

Pharmacokinetics – a branch of pharmacology – is the study of how the body interacts with administered substances for the entire duration of exposure. Studies now reveal substantial disparities in how men and women metabolise drugs and exhibit diseases. Women exhibit different pharmacokinetic properties, influencing the rate at which drugs are absorbed and distributed in the body. 

Furthermore, diseases such as cardiovascular diseases (CVD) manifest differently between sexes, necessitating tailored treatment approaches. 

Despite these findings, the biases rooted in traditional medical paradigms have impeded progress in developing gender-specific therapies, and gender bias in medical research continues to be a significant problem.

Cardiovascular diseases, which are a leading cause of mortality in women, have historically faced a shortage of gender-balanced clinical trials. The perpetuation of the male body as the medical standard has relegated women’s health to a niche, despite women constituting over half of the population. 

This gender bias in medical research has hindered the identification of crucial disease mechanisms and personalised treatment approaches.

The perpetuation of the male body as the medical standard has relegated women’s health to a niche, despite women constituting over half of the population.

Efforts to remedy gender bias in medical research are underway. Organisations like GENDRO advocate for improved data reporting and analysis related to sex and gender in research. Initiatives within academic publishing and research ethics aim to enhance transparency and inclusivity in study design and participant selection. 

However, challenges persist, including ethical considerations in including women of childbearing age in trials and the need for broader representation in research protocols to improve outcomes for marginalised groups in healthcare.

Efforts to remedy gender bias in medical research are thankfully underway. However, the exclusion of marginalised groups and women of childbearing age still abounds.

The field of regenerative medicine offers a promising avenue toward personalised therapies. Companies like MUVON Therapeutics are pioneering treatments for conditions like Stress Urinary Incontinence (SUI), addressing a previously overlooked health concern predominantly affecting women. Through tissue engineering and autologous cell therapies, regenerative medicine bypasses traditional transplant limitations, offering tailored treatments with minimal invasiveness.

While progress has been made, significant obstacles remain. Pushback against women’s health initiatives, particularly in political climates, threatens to stall advancements. 

However, there is growing global collaboration and advocacy to overcome these challenges and improve outcomes for marginalised groups in healthcare. Funding agencies and private foundations are beginning to prioritise research addressing gender-specific health disparities and the unique needs of marginalised populations.

Research that addresses gender-specific health disparities and the unique needs of marginalised populations must become a priority.

In conclusion, addressing gender bias in medical research and clinical trials requires a paradigm shift towards inclusivity and precision. By embracing diversity in study populations, prioritising gender-specific data collection, and fostering interdisciplinary collaborations, the scientific community can pave the way for more equitable healthcare outcomes. 

The future of medicine hinges on our ability to recognise and address the unique biological and social factors influencing health, ensuring that no individual is left behind in the pursuit of improved health and wellbeing for marginalised groups in healthcare.

The future of medicine hinges on our ability to recognise and address the unique biological and social factors influencing health.

To explore this topic more, listen to the full podcast episode.