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Four Reasons Women Matter in Clinical Research


I have lied to my daughters. Beyond stretching and twisting the truth about Santa, the Easter Bunny and the Tooth Fairy, I have lied. About something much more serious. Multiple times. A wonderfully empowering sentiment: "you can be anything you want to be when you grow up" followed by "anything a boy can do, you can do." Lies! Maybe not bold-faced, flat-out,100-percent-of-the-time lies but if you consider every single thing a boy can do verses every single thing a girl can do, there just are some things that are in fact gender-specific.


Between ages 7 to 10, I wanted nothing more than to be a professional baseball player. I wanted to play second base for the Kansas City Royals. At the time, I even wanted to play on a boys little league team in my small town. "You can't play on the boys team if there's a girls team available," I was told. By age 11, I was onto another wild dream - backed by my parents' affirmation of "you can be anything you want to be when you grow up" intending to inspire me while also creating an illusion that in every aspect of life, I was completely equal.


As we celebrate International Women's Day, we can proudly reflect on the gains women have made in the previous century and the first twenty years of this century. Within that time, the 19th amendment granted women the right to vote (just 100 years ago!), we have seen a major political party nominate a female as the party's presidential candidate. We have seen female pilots, astronauts, scientists, soldiers and physicians as well as electricians, mechanics, judges - Supreme Court judges - and architects. Even more recently, Barbies are no longer only white and blonde. Girls love Legos. And Minecraft. And Fortnite. Women of all ages and nationalities are engaging in the political process more than ever and just last year, six Democratic women - four with powerful campaigns who were seen as potential contenders - ran for their party's nomination. One candidate even pinky swore to multiple young ladies throughout her travels, saying "I'm running for President because that's what girls do." While the glass ceiling hasn't broken, it has weakened and now contains countless cracks and chips. A lot has changed. For the better.

According to Outsourcing-Pharma, currently women make up only 43 percent of participants in clinical trials.

However, not for women in clinical research. At a site level within the industry itself, clinical research staff members are predominately women. That is because most clinical research coordinators are licensed nurses - a field highly populated by women. But women do not participate in clinical research studies - as volunteers - at the same rate as men. According to Outsourcing-Pharma, currently women make up only 43 percent of participants in clinical trials. There are many reasons for that - and many of those reasons make sense. However, without equal representation, how can we possibly obtain results that accurately reflect how medicines affect women.


While valid, the biggest obstacle facing women in clinical research trials is the FDA's guideline established in 1977 banning women of childbearing potential from participating in early phase clinical trials. As a member of the clinical research industry, I know our primary focus is the safety of each and every volunteer who participates in clinical trials. I witness this every day. Even though each trial and each protocol are different, there is always a long list of requirements for women of childbearing age to participate in clinical trials. (It has to be said that sexually active men have requirements as well so it isn't completely one-sided.)


So, why does it matter - women in research? If we're all equal, it shouldn't matter who is testing medicines, devices and medical procedures. It benefits everyone anyway, right? Not necessarily.


Equal isn't the same

Just because we are equal does not mean that we are exactly the same. That's a lesson for Health Ed 101. There's a reason the girls have one video and the boys have a different video. Our bodies are just that - different. We may be equal in the spirit of equality but we are physically different. In fact, between 1997 and 2001, eight out of ten drugs pulled off the market were removed after being found to be more harmful to women than men.


Women matter to keep meds available

Sex-based endpoints and gender-specific data are imperative to keeping a drug available for the general public. These metrics for studying and testing medicine will be required so that these new medicines can receive FDA approval and eventually be available to help prevent illnesses and cure diseases.


Women matter to keep studies funded

Many clinical trials worldwide are funded not by big pharma but rather governmental organizations like the National Institute for Health (NIH). In 1993, the NIH mandated that women and minorities must be included in their clinical trials in order to receive funding from the NIH. As in other industries, the clinical research world also strives to have an accurate sampling of all ages and demographic groups.


Without adequate representation of women and minorities, some funding might not be available which would have a direct impact on future medicines, devices and treatments.


Women want to help too

When my niece was diagnosed with glioblastoma, my sister and her family were considering two treatment options. One was a cocktail of medications (as a result of clinical research) that was proven to slow the tumor's growth - possibly even stop the tumor's growth. The other was a clinical research study for patients like my niece. After visiting with the medical teams for both options, they chose the first treatment, not the clinical research study. My sister struggled with that decision. "What if her participation helps other kids like her?" But in the end, the cocktail offered immediate results and the ability to tweak the cocktail as needed. Immediately, she vowed to participate in a clinical research study herself. Her maternal instincts primarily wanted to save her daughter and secondarily help other children and their families.


Women want to help. Women want to prevent other families from going through trying times that they themselves have experienced. Women want to be a part of their own healthcare. More importantly, women want to make a lasting difference. For their children, grandchildren and beyond. In a recent "Female Viagra" clinical study, 23 of the 25 participants were men. Does that even make sense?! In all fairness, without seeing the protocol or understanding the purpose of the study (as there can be many and multiple purposes), I cannot report the exact details. But regardless, women's studies should predominately involve women. Because clinical research matters. Women's health issues matter. Women matter. We all do.


We will continue to strive to involve - and increase involvement of - women in clinical research. While we have yet to print T-shirts, they might say "I make a difference through clinical research because that's what girls do." And women too.


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AMR locations company-wide are currently enrolling in healthy volunteer clinical research studies. Want to learn more about clinical research and how you can get involved? Find a research center near you at www.clinicalresearchmatters.org/find-studies or visit www.amrllc.com.



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