Throughout Women’s History Month, we reached out to leaders in the clinical trial industry to hear their perspectives on women’s health and leadership. While gender representation in trials has come a long way, female-specific risk factors continue to be left out of most trials. At present, countless drugs on the market are being prescribed to women without ever having been tested on female bodies. To change this trend, the industry must shift towards a norm where women are represented across leadership and within research.
Two of the women featured in March, Dr. Kimball Johnson and Yadenis Jimenez, shared their first-hand experiences working in research and fighting for female representation across trials. Dr. Johnson is the medical director at iResearch Atlanta and iResearch Savannah as well as iAM Wellness, a nonprofit that treats patients who don’t currently have access to healthcare. A trailblazer in the HIV medical community and a steadfast leader for safety and education throughout the COVID-19 pandemic, Dr. Johnson is a fervent advocate for research in her community and has worked on over 300 trials with iResearch. Jimenez immigrated to the U.S. at age 14 and, at 27, is the owner and site director of VICIS Clinical Research Inc. based in Tampa, Florida. Passionate about learning, Yadenis has three bachelor degrees from the University of Tampa and, though her primary focus is VICIS Clinical research, is continuing her pursuit of education through a Professional Master Degree in Business. We also spoke with women on Inato’s leadership team to get their perspective on issues surrounding women in the industry. Inato’s VP of Operations and Customer Success, Raphaelle Mourey, provided her thoughts on including women in research and CSO, Liz Beatty, shared her experience rising in the pharmaceutical industry and why continued female representation is so important.
Kimball A. Johnson, M.D.
It is important to have gender equity across all research to learn the differences, if any, in the effects of any new products being studied across genders. The complex and unique differences may include hormonal effects, muscle mass, neuronal synapses, sociological complexities and drug interactions that may influence how a medication is metabolized or utilized in the human body. This makes a difference not only in the safety but in how a medication works in different people across the globe. The more information available across all the gender and genetic differences in all people makes for better research and knowledge acquired. It matters, as it benefits everyone.
iResearch Atlanta was founded by two women from opposite areas of research and life itself. There was a paucity of women in this field for a long time. They were “glass ceiling breaking” in their initial business start up and have grown a very inclusive business that is employee-centered across all genders, ethnicities and underrepresented populations.
In addition, from the beginning, a non-profit clinic was formed in conjunction with our research site with the goal of supporting those who may need assistance outside of the “insurance care” medical system as a bridge or support during times of need. This has been a critical resource to many women in the metro Atlanta area.
Raphaelle Mourey
Reaction to a treatment is conditioned by several criteria (age, race, time since diagnosis, prior treatments…), an important one being gender. To properly evaluate a new treatment, you should test it on a population that statistically represents the population that makes up the disease. We observe a predominance of males over females in trials and should work towards having a 50%-50% representation. When enrolling more women in a trial, you must ensure that you take into account female risk factors (contraception, menopause, breast diseases). This is crucial to the understanding of a drug’s efficacy.
To boost gender equity, it's crucial that sites encourage women to participate in trials as investigators or sub-investigators. Female doctors are underrepresented in trial teams, making it even more difficult to recruit and refer women. Further actions sites can take to promote referrals and retain female participants throughout all stages of trials is to share information on clinical trials to gynecologist private practices and encourage research teams to monitor gender equity at all stages of the recruitment, from the pre-screening, to screening, to the enrollment phase.
Yadenis Jimenez
In order for clinical trials to be successful, they must account for diversity. All clinical trials are meant to improve the lives of everyone with a specific illness, and female participants as they account for almost 50% of the world population, are incredibly important. For the data to be accurate and help most people, gender diversity must be required. We should not, under any circumstance, intentionally leave half of the population out of a life saving treatment merely because of their gender.
In our research center specifically, our staff is mostly female (95%). This gives us a unique perspective in understanding the challenges our female subjects face while trying to be a part of a study. This also accounts for our high female enrollment rate since females tend to feel more comfortable in an environment where they are surrounded by other females that understand their struggles and can relate to their situations. Based on these relationships we create a strong base with women that expands our reach within this demographic.
Liz Beatty
I attended a university focused on science and technology that, at the time, had a 5 to 1 ratio of male to female students. This has improved today at my alma mater where there is now a 3 to 2 ratio of male to female students. As I left university and started my career, I was pleased to find there were many women in clinical research, though few were in leadership positions. Over my career, I have seen more women advancing into executive level positions that historically were held by men. These women paved the way for other women to break through the glass ceiling. I am humbled to be continuing on the path of the female leaders before me, as a C-level female technology leader that is a member of our company’s board. However, there is still work to be done to have women equally represented at both board level and C-level positions across pharmaceutical and healthcare technology companies.
Over my career in clinical trials, both on the pharmaceutical side and now in technology, I have had the distinct pleasure to work with and for great women colleagues and leaders. Women bring diversity in their backgrounds and thinking to the pharmaceutical industry. Different perspectives and ideas are critical to address current and future challenges in healthcare, technology and clinical trials. By including women’s voices in our industry challenges, we can find new solutions that will improve the way we bring new treatments to people around the world.
Each woman featured here displayed compassion and commitment to striving for true gender equality within the industry. They continue to fight for a world where drugs are tested on and safe for women and Inato is honored to join them in that fight. Though Women’s History Month is coming to a close, Inato continues its mission to advocate for women’s health and shift the way drugmakers approach female representation in trials.