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Reducing the gender bias in clinical trials

A study of women’s participation in cardiovascular clinical trials revealed that only 38% of participants were women. But if women comprise 50 percent of the population, that should be reflected in clinical trials too.

When I was finishing up my post-doctoral fellowship, I asked myself where I thought my work could have the greatest impact: in the field, working in an academic research setting or working in clinical research with a medical device company on new medical products and technologies that would advance modern medicine. I chose the latter and haven’t looked back since. Clinical trials play a significant role in my work; they expand our knowledge of medical science and give researchers insights into the safety and efficacy of treatments and procedures.

From a researcher’s perspective a clinical trial has the power to open the door to innovative new diagnostics and treatments that can fight and prevent disease. The trial itself seems rather straightforward: test an intervention (it could be a new drug or a medical device) on a group of willing participants that have been diagnosed with the disease being treated and monitor them, paying particular attention to the safety of the new intervention and watch out for any side effects that trial participants experience.

But it’s never that straightforward. We know from past experience that different people, have different pathophysiologies, that could be based on race, ethnicity and even gender. Let’s talk more about women and their inclusion—or rather, exclusion—from clinical trials.

Women are still routinely underrepresented in clinical trials. A study of women’s participation in cardiovascular clinical trials revealed that only 38% of participants were women.

Dr. Ki Park is one of the people that I have collaborated with on clinical trials; she is an interventional cardiologist at the University of Florida Health in Gainesville.  Both an academic and a practitioner, Dr. Park is working hard to make things better for her female patients, dedicating much of her research to women’s cardiovascular health. [Editor’s Note: Dr. Park is a paid consultant of Abbott, the author’s employer]

Dr. Park can only speculate as to why women are underrepresented in clinical trials; her insights are based on the anecdotal evidence she has gathered through her research and while running the heart clinic she started at her center in 2017, where 97% of her patients are women. They include:

  • The clinical trial marketing materials created for patients don’t “speak to” women; women want to dive deeper into more details. However, when they do enroll in a clinical trial, they are more invested in contributing to the field in general and are driven by the potential to make a difference, if not for themselves, then for other women.
  • Follow up care in clinical trials can be incredibly onerous for women; they have complex lives caring for children and elderly parents, running a household, and working. If they are expected to take time out of their busy schedules for in-person visits to a clinic, they often won’t enroll.
  • The absence of female principal investigators means women aren’t seeing themselves reflected in the people who are treating and caring for them. Part of this includes communicating in a way that makes them more willing to enroll in clinical trials.

That last point is something that needs to be addressed by medical schools. Dr. Park points out the disparity in the number of female cardiologists is a reflection of the disparities in women’s cardiovascular care. She considers herself the exception to the rule in her field where only 4% to 6% of all interventional cardiologists are female. Even in general cardiology, she says only 20% are women. This number has remained constant for years.

When female medical students don’t see female cardiologists, it translates into fewer women in academics, fewer female interventional cardiologists in the field and fewer women doing research, she believes. It may not be intentional, but she thinks it also translates into less focus on the recruitment of women enrolling in clinical trials. Investigators are not willfully overlooking this, they just don’t actively think about it.

So what can we do to reduce the gender bias in clinical trials and ensure the best outcomes?

For starters, we are raising awareness of the problem and evangelizing the need to reform the clinical trial ecosystem and how clinical trials are designed so that it becomes standard practice to include women as an accurate percentage of the general population. 49% of patients with heart disease in the United States are women, yet just under 30% of participants in clinical trials that involve percutaneous coronary intervention (PCI), to clear blockages in arteries have been women.

As Dr. Park puts it, “If women are 50% of the population. We should be 50% of clinical trials and we’re not.”

Exposing stigmas is another challenge we are addressing; women’s health symptoms have historically and routinely been dismissed by physicians as psychosomatic. Telling a woman that her symptoms are “all in your head” is not only discriminatory, but it perpetuates stereotypes about women and mental health in general. There is plenty of research and evidence that cardiovascular diseases present differently—and often later—in women than men. Ignoring a patient’s hunch that “something is wrong” could also lead to dire consequences. I am particularly concerned for the health and well-being of women as they cross over into middle age—concerned they are being marginalized to the point they are not receiving the treatment they need.

The journey to more mindful inclusion of women in clinical trials will be a long one. In the meantime, small steps must be taken to improve the situation, and hopefully improve outcomes for women. We are starting by:

  • Creating literature for clinical trials that are designed with language for a female audience.
  • Recruiting female principal investigators who do research on women’s cardiovascular health.

A big component of closing the gender gap in clinical trials is really about taking the time to listen to the concerns of female patients and developing the right solutions to address those concerns. If I can make a difference in the design of clinical trials and that means improving health outcomes for women like me, then I think it’s worth the effort.

Jennifer Jones-McMeans, PhD, is the Divisional Vice President of Global Clinical Affairs for Abbott’s Vascular Business based in Santa Clara, California. Since joining Abbott as a clinical research scientist nearly 14 years ago, Jennifer has worked on gaining approval of numerous vascular devices, in the USA and around the world. She has led many clinical trials, including those for resorbable technologies designed to treat cardiovascular disease and peripheral arterial disease, the latter of which disproportionately affects, African American, Native American and Latino communities. Through her work, Jennifer has become one of the leading experts in clinical trial design strategy for vascular devices

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