When I finished my postdoctoral research, I asked myself where I think my work can have the greatest impact: in this field, working in an academic research environment or working with medical device companies in clinical research on new medical products and promoting the development of modern medicine Technology. I chose the latter and never looked back since. Clinical trials have played an important role in my work. They expand our medical knowledge and give researchers insight into the safety and effectiveness of treatments and procedures.
From a researcher’s perspective, clinical trials have the ability to open the door to innovative diagnoses and treatments that can fight and prevent diseases. The trial itself seems fairly simple: test interventions (perhaps new drugs or medical devices) on a group of volunteers who receive treatment and monitor them, paying special attention to the safety of the new drugs. Intervene and pay attention to any side effects experienced by trial participants.
But it has never been that simple. We know from past experience that different people have different pathophysiology, which may be based on race, ethnicity, or even gender. Let’s talk more about women and their inclusion—or rather, their exclusion from clinical trials.
Women are still underrepresented in clinical trials. A study on women’s participation in cardiovascular clinical trials It was revealed that only 38% of the participants were women.
Dr. Ki Park is one of the people I have worked with in clinical trials; she is an interventional cardiologist at the University of Florida Health Center in Gainesville. Whether a scholar or a practitioner, Dr. Park is working hard to create better conditions for her female patients, and most of her research is devoted to women’s cardiovascular health. [Editor’s Note: Dr. Park is a paid consultant of Abbott, the author’s employer]
Dr. Park can only speculate why women are underrepresented in clinical trials; her insights are based on anecdotal evidence she collected through research and opened a heart clinic at her center in 2017, 97% of which are women. They include:
- The clinical trial marketing materials made for patients will not “talk” to women; women want to know more details in more depth. However, when they participate in clinical trials, they are more invested in their overall contribution to the field and are driven by the potential to be affected, if not for themselves, then for other women.
- Follow-up care in clinical trials can be very burdensome for women; their lives are complicated and need to take care of children and elderly parents, run a family, and work. If you want them to take time out of their busy schedule to go to the clinic in person, they usually don’t register.
- The absence of the female lead investigator means that women do not see themselves reflected in the people treating and caring for them. Part of this includes communicating in a way that makes them more willing to participate in clinical trials.
The last point is the problem that the medical school needs to solve. Dr. Park pointed out that the difference in the number of female cardiologists reflects the difference in women’s cardiovascular care.She considers herself an exception to the rules in her field, only 4% to 6% of interventional cardiologists are womenEven in general cardiology, she says that only 20% are women. This number has remained the same for many years.
She believes that when female medical students cannot see female cardiologists, it will lead to a decrease in the number of women in academia, the number of female interventional cardiologists in the field will decrease, and the number of women engaged in research will also decrease. This may not be intentional, but she believes it also means less attention to recruiting women to participate in clinical trials. Investigators did not deliberately ignore this, they just didn’t think positively.
So what can we do to reduce gender bias in clinical trials and ensure the best results?
First, we are raising awareness of the issue and advocating the need to reform the clinical trial ecosystem and the way clinical trials are designed so that it becomes standard practice to include women as an accurate percentage of the total population.In the United States, 49% of heart disease patients are women, but slightly less than 30% of clinical trial participants involved percutaneous coronary intervention (PCI), women who clear arterial blockages.
As Dr. Park said, “If women make up 50% of the population. We should have 50% clinical trials, but we don’t.”
Exposing stigma is another challenge we are dealing with; women’s health symptoms have traditionally and often been regarded as psychosomatic diseases by doctors. Telling a woman that her symptoms are “all in your mind” is not only discriminatory, but also perpetuates stereotypes about women and general mental health.There are many Research and evidence The manifestation of cardiovascular disease in women is different from that in men, and it often occurs later. Ignoring the patient’s “problem” premonition can also lead to dire consequences. I am particularly worried about women’s health and well-being when they enter middle age-worried that they will be marginalized to the point where they cannot receive the treatment they need.
The journey for women to participate more cautiously in clinical trials will be a long one. At the same time, small steps must be taken to improve the situation and hopefully improve the outcome for women. We start with the following:
- Create literature for clinical trials, designed in the language of a female audience.
- Recruit a female lead researcher who is engaged in research on women’s cardiovascular health.
An important part of closing the gender gap in clinical trials is actually taking time to listen to the concerns of female patients and develop the right solutions to address these concerns. If I can make a difference in the design of clinical trials, which means improving the health outcomes of women like me, then I think it’s worth the effort.
