Guest Column | January 10, 2024

Why We Need More Women In Clinical Research — Now

By Juan Camilo Arjona Ferreira, chief medical officer, Organon

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A growing body of research and literature shines a light on the many aspects of our world that have been designed with less consideration for women’s needs, including everything from public transport systems to smartphones to voice recognition technologies, and even standard office temperature settings.

In some cases, society’s tendency to view the male body as “default” has had relatively benign, if not uncomfortable, effects. But in other cases, historic gender biases can have serious consequences. Such is the case when it comes to healthcare — where research, attention, and investment have long favored men’s needs.

This has led to the situation we find ourselves in today, where women’s health needs are too often dismissed, downplayed, or deprioritized. Women wait longer than men for both a diagnosis and pain relief and are more likely to be discharged during serious medical events. The state of affairs is even more dire in areas where many women are affected by forced displacement and gender-based violence, such as my home country of Colombia, where I trained and practiced as an OB-GYN. But gender-related health disparities know no borders. Consider the U.S., where the trends are also slipping backward: The maternal mortality rate has been on the rise since 2000, with Black women at greatest risk.

In addition, in 1977 the FDA issued a guideline that effectively banned most women of “childbearing potential” from participating in clinical research. It was not until 1993 that the FDA revised this guidance, contributing to pervasive blind spots and risks. For example, one study found that women experience adverse drug reactions nearly twice as often as men. The data gaps have precipitated an unfortunate domino effect: Less research in this area means we have fewer drugs targeted to women’s health needs, that can then contribute to underfunding by a male-dominated investor community that lacks an in-depth understanding of the untapped opportunities. Ultimately, it’s women who pay the price — often in the form of chronic and painful symptoms from intractable conditions like endometriosis — or worse, dying from uncontrolled hemorrhage during childbirth.

It is time we prioritize research that brings women’s needs into sharp focus.

3 Ways To Catalyze More And Better Solutions For Women

Having spent much of my career working in women’s health — currently at Organon — I have seen firsthand what it takes to accelerate innovation. It requires a new model grounded in three key pillars: investment, engagement, and equity. When implemented, this model can drive forward important changes needed to advance research in overlooked areas.

Investment

For potential new treatments to even have a chance at reaching the lab bench, we’ve got to start by addressing one of the most significant root causes of women’s health disparities, which is the lack of capital allocated toward this space. It is only in the past couple of years, in the wake of the reversal of Roe vs. Wade in the U.S., that we have seen investment in women’s health tick up, surging to an all-time high of $3.3 billion in 2022. But let’s put that to scale: The investment in US sports teams has already grown to an estimated at $205.9 billion in just 5 years in 2019, when professional sports leagues allowed private equity funding. While I love the thrill of watching sports as much as anyone, it doesn’t take an economist to recognize that something seems askew.

We need to send the investment community a clear, compelling message: Women’s health is rife with opportunity, not only because of the pressing need for more options to treat everything from heavy periods to postpartum depression and menopause-induced hot flashes but also because it makes good economic sense. Estimates suggest that every $1 spent on addressing unmet needs for family planning would yield $120 in health and economic benefits, and investing further in women’s equality could add between $12 trillion and $28 trillion to global growth. Further, the health of women is directly linked to the health of their children and communities, creating an environment where businesses and economies can thrive. I’m encouraged by the recently announced White House Initiative on Women’s Health Research, which aims to galvanize the public, private, and philanthropic sectors to unleash investment to close research gaps. With influential leaders at the table, coupled with sustained funding and commitment, we have the power to shape a brighter future for the health of women worldwide.

Engagement

To shift away from a status quo where male physiology is viewed as the default in clinical research, it is imperative that we center the unique experiences and perspectives of women from all backgrounds and life stages. A great place to start is designing clinical trials that emphasize Patient-Reported Outcomes (PROs). PROs provide a critical avenue to give women a voice in shaping what outcomes are most important to them when evaluating the efficacy of potential new innovations. For instance, researchers developed the Endometriosis Symptom Diary and the Endometriosis Impact Scale, which are designed to assess efficacy endpoints in clinical studies using symptoms that women with this condition deemed most bothersome. Additionally, in migraine – a debilitating condition that disproportionately impacts women – patients rated reduction in monthly headache days, monthly migraine days, and headache pain intensity as the most important metrics. By engaging patients to help us identify PRO measures for other conditions, we pave the way for innovations in areas where current treatment options may not adequately meet women’s needs. 

Equity

Foundational to all of these efforts is cultivating a pipeline of scientists, researchers, and healthcare professionals who fully comprehend women’s health challenges. In fact, studies show that women are more likely to invent medical treatments for endometriosis, cervical cancer, and other female conditions. Yet, according to a United Nations report, women researchers tend to have shorter, less well-paid careers, and are typically given smaller research grants than their male colleagues. This means we’re potentially missing out on new innovations by and for women, and also losing out on their unique insights. We must do more to support women in life sciences, strengthen pay equity policies and make certain that both women and men have access to benefits like flexible work, paid leave, and childcare support that allow them to balance their careers and families.

Without question, much work needs to be done to create a more equitable and inclusive environment for women’s health research. But I remain optimistic, because the progress we have seen in recent years reminds us that change is possible.

About The Author:

Juan Camilo Arjona Ferreira, MD, is the head of research & development and chief medical officer of Organon, a global healthcare company formed to focus on improving the health of women throughout their lives. He has more than two decades of clinical research and development experience and a strong background in women’s health. Earlier in his career, Dr. Arjona Ferreira practiced as an OB-GYN in university hospitals and private practice.