A Look Back Allows A Path Forward In Clinical Trials

Celebrating Women’s History Month by reducing gender inequity in research efforts

Sustainability|Mar.25, 2022

What’s past is prologue.”

William Shakespeare, The Tempest

In other words, history establishes the framework for what the future holds. Which is why it is so important, as we celebrate Women’s History Month, that we examine the gender inequities of our past to improve the future of women’s health.

As part of our efforts, we are placing a particular focus on clinical trials - cornerstones of medical progress - which are used to evaluate the safety and effectiveness of healthcare products in the diagnosis, prevention and treatment of disease. These trials have long been designed with one simple goal:

Provide the best care options to all people in need.

But, like many simple goals, this one can be rather complex to meet. As it turns out, within that, “all people,” there's a whole lot of different demographic groups who have a whole lot of different medical conditions, who live in a whole lot of different places, and…you get the idea. For years, clinical trials were comprised, primarily of white, male subjects, resulting in various racial, gender and ethnic groups being under-represented, which in turn has resulted in medical options that fell short of the, “best care options to all people in need.”

Fresh Perspectives Lead to New Solutions

The solution to this long-standing problem may be deceptively simple. “If you make trials more inclusive, the results from those trials will be more useful,” said Dr. Roxana Mehran, Director, Center for Women’s Heart Health at Mt. Sinai Hospital in New York. She is also the Director of the Center for Interventional Cardiovascular Research and Clinical Trials at the Wiener Cardiovascular Institute within the Icahn School of Medicine at Mount Sinai. She is a physician deeply immersed in the worlds of cardiac care and clinical trials.

Dr. Mehran is a strong advocate for greater diversity, including gender equity, in all aspects of clinical trials. She understands the key to obtaining the highest quality clinical trial data starts at the top of the team and at the beginning of the process. “We need intentional, deliberate and well-planned efforts to train interested women to conduct important research. We have to approach new solutions from different directions with different outlooks, filling these important seats with new, trained, talented researchers.”

While she respects the exceptional work that other clinical trialists have always conducted, she has also seen how success can lead to some stagnation, with the same group of investigators leading trial after trial, because it is the safest path to pursue. “When we have the same people conducting the same type of research over long periods of time, we get the same results. We need fresh perspectives from different backgrounds to truly innovate,” said Dr. Mehran.

The Times They Are A-changin’

The medical field generally has seen significant gender-based changes in recent years. In 2017, while the number of male physicians in the U.S. still substantially outnumbered women, for the first time, the number of women enrolled in medical school surpassed men. Also, a 2017 survey found that of 18,000 physicians in 3,500 practices on the athenahealth network, 60 percent of respondent physicians under the age of 35 were female.

Yet even this promising news does not necessarily translate into substantially increased gender equity in clinical trials, other research, or leadership positions. The Association of American Medical Colleges (AAMC) 2018-2019 Board of Directors published their conclusion that women continue to be underrepresented in the physician and scientific research workforce, even with the parity in student numbers. They likewise found women were not promoted as quickly in academic positions and, in several non-primary specialty areas, women were significantly underrepresented. For example, only 18% of cardiology specialists are women.

The AAMC also identified a gender gap in peer-reviewed publication authorship and found that men were more likely to be granted positions as first or senior authors on published papers. Given that information, it is perhaps not surprising that males receive more research funding and are more likely to be on grant approval boards, as well.

Opening Up a World of Possibilities

None of this is news to Dr. Mehran who has worked exceptionally hard to establish herself as a leading researcher (1200+ publications) and expert in interventional cardiology. She does not look for targets to blame for these inequities but rather seeks out solutions that benefit all. “These are not networks of people who are intentionally trying to monopolize clinical research. People want to work with those they are most familiar with. That’s just human nature.

“What we need to do is open up that world of professionals who are familiar faces, because there are a lot of smart people with exciting ideas, hungry to share their talents. And the changes that need to be made shouldn’t be limited to academic institutions, but rather cover all entities that sponsor the research and make these decisions, including corporations.”

Dr. Mehran’s quest is clearly for the best and the brightest researchers. “This should never be about ensuring that x number of investigators come from any particular group, just as none should be excluded. Rather the focus should be on the deliberate effort, over time, to train up qualified individuals who will get ongoing experience and establish long-term success.

“We always want experienced researchers who have established knowledge that make trials more efficient and better. But without new, diverse voices, original thoughts and approaches, we are limiting what we can accomplish.”

Gender Inclusivity Leads to Benefits For All

One of the primary benefits of expanding the role of women clinical trialists is the associated inclusion of, and impact upon, female patients. The issue of gender bias is not new but it’s also not leaving on its own. In 2019, a study covering 25 years of research found that while the total number of women who had been studied was almost half of the total subjects, women were underrepresented in several areas, including cardiovascular disease.

One woman who is extremely aware of the numbers involved in this world is Dr. Ki Park, an interventional cardiologist at the University of Florida-Gainesville. She sees the mere 4% of interventional cardiologists who are female as a sign of the disparities inherent in women’s cardiovascular care. “When female medical students don’t see female cardiologists, I believe that translates into fewer female academics, fewer doing research,” said Dr. Park.

“While this may not be intentional, it may well translate into decreased focus on recruiting women into clinical trials. While investigators may not be willfully overlooking this, they also may not be actively thinking about it.”

Dr. Park can only speculate as to why a mere 38% of cardiovascular trial subjects are women. “We are 50% of the population. We should be at least 50% of clinical trials.” She does, however, have thoughts as to why there is not a larger percentage of women involved in trials:

  • Clinical trial marketing materials created for patients don’t “speak to” women. When they enroll in a clinical trial, they are more invested in contributing to the field in general, driven by the potential to make a difference, if not for themselves, then for other women.
  • Follow up care in clinical trials can be tough for women They often have complex lives caring for children and elderly parents, running a household, and/or working, and cannot find time for in-person visits to a clinic.
  • The absence of female principal investigators means women aren’t seeing themselves reflected in the people who are treating, and caring, for them.

Dr. Park agrees that it is vital to future care to encourage female enrollment. “We can’t provide the best care for women if we don’t have data collected from women.” Like Dr. Mehran confronting the challenge of too few female investigators, Dr. Park sees the solution to insufficient female enrollment as having multiple components:

  • Industry can set internal goals in their clinical trials, pledging to include more women and underrepresented minorities in their studies. Companies can influence change if they make it part of their mission.
  • Offer training for investigators on applying a gender lens to their research; if they are cognizant of the need for greater diversity in their studies, they will be more mindful of who they approach to enroll.
  • Focus on patient education and general information. If patients know their participation in clinical trials translates into better cardiovascular care for women, they might be more willing to participate in the research.

Perhaps Dr. Mehran best summarizes the need to increase enrollment, improve trials and enhance care when she notes,” Only when we recruit more women into clinical trials can we establish clear, women-focused guidelines. It’s time we stopped talking about it and took urgent action.”

By embracing this need to act quickly, we position ourselves to celebrate future Women’s History Months by studying our present. Or to put it another way:

" It’s not in the stars to hold our destiny but in ourselves."

William Shakespeare, Julius Caesar