Women account for nearly half the human population (49.6%), but are often excluded from clinical trials and medical research. Unfortunately, this lack of inclusion has real-world consequences. 

A recent study published in the Annals of Internal Medicine found that women are more likely to report negative experiences with health care, have their medical concerns dismissed, and have heart symptoms or pain ignored. These findings would be almost unbelievable if the data weren’t there to back it up. But how did we get here? And, why are women so commonly overlooked? This white paper explores the history of women-centric medical research and explains what’s being done to make improvements.

Why are women often excluded from clinical trials?

Sadly, excluding women from clinical trials isn’t a new phenomenon. Up until the late 20th Century, medical research was predominately male-dominated, and decision-makers specifically sought out male trial participants because women’s hormones were considered too ‘unpredictable’. Scientists argued this unpredictability would introduce too much variability into carefully crafted trial protocols and in turn, affect the accuracy of results. 

Nowadays, we know this thinking is bogus, but biases regarding women clinical trial participants remain. It wasn’t until 1993 that the National Institutes of Health (NIH) mandated the inclusion of women in clinical trials. This groundbreaking decision helped move things in the right direction, but it wasn’t as much of a watershed moment as you might think. 

Consider that many “standard” inclusion and exclusion criteria drafted into clinical trial protocols automatically disqualify women candidates. Moreover, much of what’s considered “standard” in our modern health care system was developed by men, for men, with little thought to how the same drugs and therapeutics impact the female anatomy. 

In other words, the physiological and hormonal differences between men and women have been significantly overlooked. Research results are often skewed or inaccurate as a result, and women are less likely to participate in clinical trials because of their past experiences with the male-centric medical profession. 

Addressing systemic and data gender bias through tangible changes

The reality is that it will take time and effort to change the foundations of medical research. The current system has had over 100 years to establish itself and old habits die hard. But it’s not all doom and gloom. Progress is already being made! 

For instance, President Biden signed an executive order earlier this year, that will “expand and improve research on women’s health.” More specifically, the order aims to ensure women’s health is “integrated and prioritized across the federal research portfolio and budget.” The order also includes the launch of a new NIH-wide effort that, starting in 2025, will dedicate $200 million to fund new, interdisciplinary women’s health research. 

Additional funding and focus is a great first step, but it isn’t the only solution. For real change to occur, researchers must work to identify and weed out built-in gender biases, and trial designers must refine experiments and data analysis to account for gender differences. The good news is this is already happening. Over the last few years, several funding agencies and medical journals have established guidelines to incorporate sex and gender into research protocols. 

Industry experts say there are several other things the medical community can do to keep making progress. These include:

• Attracting and retaining a diverse group of women in leadership roles for medical and clinical research
• Incorporating how biological sex differences affect medical care into medical education
• Increasing the robustness of inclusive research and data collection
• Recruiting women from underrepresented demographics (e.g., women of color, older women, and women living in rural areas)

Achieving these goals will require a willingness to adapt and change, but the life sciences industry is up for the challenge. Progress is all around, you just have to look. Positive policy changes are happening, inclusive study designs are becoming the new normal, and the disparities between men’s and women’s health care are more widely known. 

Increase patient diversity by partnering with a CRO

Now, more than ever, regulators expect biopharmas to include diversity & inclusion when recruiting patients for clinical trials. The FDA’s 2020 Drug Trials SnapShot Report found that among clinical trials for new therapeutic biologics and molecular entities, only 8% of participants were African American, 11% were Hispanic, and 6% were Asian. Clearly, there’s room for improvement. But if you aren’t familiar with recruiting diverse patient populations, it can be challenging to know where to start.

Partnering with a CRO that includes diversity and inclusion in its mission can help. These experts can also provide feedback on leveraging adaptive trial designs and how protocols can be changed to encourage a more inclusive recruiting environment. 

To learn more about the CRO services we provide, call (781) 775-0342 or send an email to [email protected].