Strategies needed to increase female representation in CVD clinical trials
Click Here to Manage Email Alerts
CVD is responsible for approximately one in three deaths among women in the U.S. each year, yet only 38% of participants in clinical CVD trials are women, according to the American Heart Association.
Data also show that women continue to be underrepresented in clinical trial leadership, which in turn affects the recruitment of women as participants in clinical trials, according to Amy M. Ahnert, MD, and Deborah W. Sundlof, DO, co-directors of the Women’s Heart and Vascular Program at Lehigh Valley Health Network (LVHN). These imbalances are more than just number discrepancies; the lack of women at every level in clinical trial design has implications for drug development, future research and health outcomes, Ahnert and Sundlof said.
Image: Adobe Stock
Healio spoke with Ahnert and Sundlof about how a lack of female participants in clinical research impacts women’s health, strategies to help increase women’s participation in trials and how cardiologists can take small steps in their own communities to increase gender diversity in research.
Healio: Why do women remain underrepresented in CV trials? What factors are at play?
Sundlof: There are many factors that tend to fall under two main categories: patient barriers and institutional barriers. When we say institutional, I mean physicians, providers and our scientists. There is a lack of diverse leadership in clinical trials. We know that when trials are led by women, trials tend to recruit more women.
There is also a bias due to the mindset to “do no harm.” As a result, we tend to not recruit women of childbearing age, in case they are pregnant and could potentially be exposed to a harmful intervention. We need to include women of all ages so we can see how therapies affect women.
Ahnert: There are also factors related to the patient. Women may have different barriers that affect their likelihood to enroll, such as child care needs, particularly young women. We need to address these barriers effectively if we are going to increase representation of women.
Another thing we have learned is women may respond differently to information about a trial. Historically, when speaking to patients about a trial, we have a strict way we present information. Women may have different concerns, and those concerns may not be addressed. We have to take these sensitivities into account when speaking with women about trials.
Healio: What are the consequences of missing these women? Why is it important to increase representation of women in CV research?
Sundlof: Women are not small men. We see that most clearly in our heart transplant data. When a man’s heart is transplanted into a woman’s body, they fare well; however, when we transplant a woman’s heart into a man’s body, men fare worse. This is likely due to more than just the size of the heart; there may be something hormonal or immunological that is different. It is important to understand these differences, as it makes a difference in the therapies we have to offer.
Ahnert: Historically, we have taken data from trials that have had predominantly male participants, and we extrapolate that data to women, and we presume it is going to be the same. We are learning that that is not the case. There are several specific reasons.
The first is we have learned that women have different risk factors than men. Not all risk factors are created equal. We know that adverse pregnancy outcomes, for example, can carry a significant risk for CVD, as can autoimmune diseases, breast cancer treatments, depression and anxiety. If we do not have a way of understanding and researching that, we cannot effect changes to improve outcomes.
The second is women can have different symptoms from men. We need to understand the differences in how women present with CVD compared with men to make changes in bettering and improving outcomes for women.
Sundlof: We also know when women present with MI that they have worse outcomes than men. This is for multiple reasons. Women are more likely than men to delay seeking help. They also tend to call someone else before calling 911. They present with different symptoms. They are also less likely to receive guideline-directed therapies, and when they do, they still have worse outcomes. We need to find out why that is so we can close those gaps. Women also have CVDs that are specific to women, such as spontaneous coronary artery dissection, or SCAD, which can be seen in men but is predominantly seen in women. This needs to be identified because it is treated differently. These patients may not need a stent, or aspirin or bypass surgery.
Healio: Can you highlight some of the work you are doing at LVHN to expand access to clinical trials for women? What is working, and why?
Ahnert: We have built one of the country’s largest women’s heart and vascular programs. When we created this program, we knew that research was an important focus and had to be a priority for us. We know that we need to be at the table, participating in research to increase the recruitment of women into clinical trials.
I am a principal investigator for the REBIRTH trial, designed to look at women who have peripartum cardiomyopathy, which can be a life-threatening condition. We are randomizing patients to a medical treatment to see if we can improve their outcomes. One of the fascinating lessons from participating in this trial is you would think we wouldn’t have any barriers enrolling women. We have realized that how we speak with women, present information and communicate with women makes a big difference in whether they chose to enroll in a trial. We need to be gender-sensitive in how we are presenting trial information to try to encourage women to participate. We are forming support groups for these patients, because many feel so isolated that the thought of enrolling in a trial can be daunting or overwhelming.
Sundlof: We started the women’s heart and vascular program in 2011. Our big focus is bringing women together to take care of women. We have 11 women CV specialists and we push them to get involved in research. I’m a principal investigator in the ATRIUM trial, which is focused on immune checkpoint inhibitor-induced myocarditis. Again, we know studies led by women recruit more women. We try to be flexible, seeing these women during “off” hours, allowing participants to bring their young children if needed.
We are both investigators for the LUX trial, which is placing a tiny monitor under the skin to monitor people with congestive HF. This helps us diagnose preclinical HF, before the patient even has symptoms. We want to tailor therapies that are gender-specific to help our patients.
Healio: What further research is needed in this area?
Ahnert: We don’t know what we don’t know. But the reality is that we do know a lot and we have made a lot of change and impact. We are continuing this battle to understand gender differences in CVD. As we learn more, we need to dive further to understand what we do about all of this. If we understand that there are differences in how women present with heart disease, in their risk factors for heart disease, how they benefit from different treatments and testing modalities, then what do we do about it? The answer is to do more research to close the gaps in outcomes and gaps in care. Increasing women’s representation in trials can help close those gaps.
It starts with the patient and the clinical relationship. Physicians can take the lead and bring a patient into a research trial that is appropriate for them, so we can learn more. This can seem daunting, but providers can have impact with small steps. You just have to look and see what is going on in your own hospital and community and include gender in that. Are there worse outcomes in women in your hospital or your communities? Are women not getting the medications they should, or not being referred for certain programs, like cardiac rehab? Then you can spearhead programs, as we have, to address those differences. You can act in your own community and have an impact.
Sundlof: We have really pushed our colleagues to choose a passion. What is your passion? Then, become an expert in it. One of my passions is cardio-oncology. We know certain breast cancer treatments can cause CVD. We want to conduct research in this field and ensure as providers that we are not working in silos. Patients want to know that if they have cancer and a treatment may affect their heart, that their cancer doctor is talking to their heart doctor and vice versa. At LVHN, we have broken down those barriers and created care teams to ensure the best care possible as we continue this research into gender care gaps.
For more information:
Amy M. Ahnert, MD, can be reached at amy_m.ahnert@lvhn.org. Deborah W. Sundlof, DO, can be reached at deborah.sundlof@lvhn.org; Twitter: @DeborahSundlof.
Collapse
Healio Interviews
Read more about
Click Here to Manage Email Alerts