Guest Column | April 22, 2024

Yes, Women's Exclusion In Clinical Trials Is Still A Problem

By Somer Baburek, president and CEO, Hera Biotech

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As a female founder with a background in clinical operations and venture capital, I’m compelled to highlight how women have been given the short end of the stick when it comes to clinical trials.

Historically, women have been excluded from clinical trials. Why? Well, the predominantly male body of researchers thought our hormones were too unpredictable and would introduce too much variability into carefully crafted protocols. And don’t get me started on the fear of pregnancy messing up their data. The fear of hormonal variability in subjects was so deep that researchers even excluded female mice from preclinical studies to reduce it. It wasn’t until 1993 when the NIH mandated the inclusion of women in clinical trials that a significant turning point in medical research started to occur.

Then, the default participant in clinical trials was a 150-pound white male. Despite the mandate, I haven’t seen a lot of behavior change on the industry side. When drafting clinical trial protocols there are still “standard” inclusion/exclusion criteria that disqualify women for critical research trials. The result? Every woman is operating in a healthcare system that fundamentally wasn’t designed for or by women, and a vast majority of interventions and the data about their efficacy are based solely on response in male bodies. This is the equivalent of being forced to shop in the men’s department and the only modification you can make is the size.

This arbitrary standardization has neglected the physiological and hormonal differences that exist between men and women, potentially leading to skewed results that did not accurately reflect a diverse patient population. But the damage goes even further. I now am running a company that addresses diseases that uniquely impact women’s health, and every day I am faced with additional hurdles as a result of the exclusionary history in clinical trials.

First, women are harder than men to recruit. What I find is that conditions that are specific or unique to women have suffered from a lack of research and a lack of research funding. Therefore, very little is known about them. We don’t have robust diagnostics for them (our area of focus), we don’t track their progression very well, and we have limited treatments for them. Additionally, as a result of this dearth of knowledge, women often have the symptoms of these diseases dismissed by medical professionals, and getting a definitive diagnosis can take years as a result. In the case of endometriosis, which is our lead indication, the average time to diagnosis is eight years and requires surgery. This means that by the time a woman has convinced a medical professional that her symptoms are, in fact, symptoms and not just in her head, she has been emotionally and physically exhausted by the medical community, and the idea of adding “one more thing” – like clinical trial participation – to the process of diagnosis can be just too much.

Second, as a clinical trial professional, I don’t think I’m going out on a limb to say that the FDA has never been accused of being flexible. Rightly or wrongly, the agency has carefully crafted a rigid structure for what they consider sufficient evidence for product approvals. Often, this structure includes a number of animal models, healthy human volunteer studies, validation of algorithms in massive data sets that can be gathered through databanks, and then prospective studies in intended use populations. So, what happens when even the animal models exclude females? What happens if you’re working on an indication that doesn’t benefit from decades of well-funded research and multiple databanks filled with indication-specific data about women’s bodies?

You see, excluding women from research in the past affects their ability to participate and have products developed for them even today. Addressing this systemic and data gender bias will require a multifaceted effort that includes research funding agencies, like the NIH, and patient outreach to encourage and help women participate in clinical trials and reduce burdens of doing so. I also think it will require — dare I say it — flexibility from the FDA to understand the extensive limitations faced by companies developing solutions in this area of high unmet need.

Despite the progress made in including women in clinical trials, challenges persist. Researchers must be vigilant to ensure their work does not perpetuate the data and research gaps for women. We must seek ways to refine experimental design and analysis to account for gender differences. The push for more nuanced and gender-specific research is gaining traction, as scientists recognize the importance of understanding how all genders respond to medical interventions. 

But it's not all doom and gloom. With more and more bad-ass female scientists and advocates leading the charge, we're starting to see progress. From pushing for policy changes to advocating for more inclusive study designs, we're making strides toward a future where women aren’t treated as challenges to medical research.

About The Author:

Somer Baburek currently serves as the president and CEO of Hera Biotech, a women’s health company focused on commercializing a non-surgical diagnostic for early detection of endometriosis. Prior to founding Hera, Somer spent 10 years in life sciences venture capital and served as the director of clinical operations for Santalis Pharmaceuticals.