Racial diversity in clinical trials is top of mind, and rightfully so – most everyone in clinical research agrees in principle that improving ethnic representation in trials will result in better research outcomes and help to address treatment inequities in healthcare overall. As an industry, demographic representation in trials is a moral – and increasingly legislative – imperative. We should be doing more to design and recruit for trials that are more representative across a number of criteria; this is a topic that Hawthorne Effect has addressed before and is central to our founding.
The implications for how those trials are designed and executed are wide-reaching. Hawthorne Effect has worked on a vast number of trials treating all manner of conditions and diagnoses, but one particular area of expertise for us has been cardiovascular trials. When we consider the ramifications of inclusion in cardiovascular research, several important points come to the forefront.
Heart disease is still prevalent, and treatment gaps still exist
In 2023, heart disease remains the leading cause of death in the United States; this is true across genders and across most ethnic groups. We know a fair amount about key risk factors that contribute to heart disease – namely, smoking, high blood pressure and cholesterol, diabetes, obesity, poor diet, and limited exercise – but treating cardiovascular conditions still constitutes a significant portion of healthcare resources around the world.
Moreover, racial inequities in access, treatment quality, and follow-up for conditions such as heart failure have been well-documented and remain an important consideration in healthcare delivery, so it is no surprise that similar gaps exist in cardiovascular research. Whether the cause is skepticism toward the healthcare system generally; hesitancy at being treated as a “subject”; or common socioeconomic barriers to access, the lack of greater minority representation in trials undoubtedly perpetuates disparities in delivery and overall patient outcomes.
Multiple types of diversity are important in cardiovascular clinical trials
Going further, socioeconomic factors cut across racial lines and are wider determinants of whether one can, and will, participate in clinical trials. When we look at cardiovascular research, the traditional model of conducting trials exclusively within brick-and-mortar sites that might be inaccessible to many patients – even at notable or renowned heart or cardiovascular treatment centers – creates a natural limitation on recruitment, potentially delaying the introduction of new therapies to the market. Similarly, it could result in therapies being introduced that do not adequately address the needs of underserved populations.
Gender is an equally important consideration given the differences in symptom presentation, diagnosis and prognosis, treatment, and more for many aspects of heart disease. As the implications for identification and treatment of cardiovascular issues for women continue to be explored; so, too, should the significance of gender difference be a factor when designing for cardiovascular clinical trials.
Health equity makes business sense – including for clinical trials
The Hawthorne Effect Mission Statement boldly states that we seek “hope for better lives and health.” That speaks not just to inclusivity and equity, but ultimately to patient outcomes that span all populations – and that patient journey begins with medical research being accessible to those populations. It stands to reason that marginalized groups may be more likely to embrace new therapies if they are included in studies, which means that the bottom line actually begins being drawn with clinical trials.
Cardiology clinical trials are complicated, lengthy, and costly in both financial and human resources. But again, they seek to find ways to mitigate the leading cause of death in this country, which necessarily calls for ensuring all patient groups are represented in research. This ultimately means better clinical outcomes for patients and better business outcomes for healthcare delivery partners.
Diversity in cardiovascular trials is achievable today
Ensuring representative patient populations are included in cardiovascular research is not some far-off, futuristic vision, as Hawthorne Effect is achieving this today. One recent trial that we’ve been proud to be a part of is the PREVUE-VALVE study, an unprecedented prevalence study that aims to quantify the true frequency of valvular heart disease (VHD) in a demographic representative sample of the U.S. population. This will ultimately help in the development of new therapies for a disease that affects older patients of all backgrounds, and it could not have been done without looking beyond traditional trial designs.
The goals for this study remain ambitious, and our approach to access and enrollment has helped to ensure trial people from all walks of life and geographies have been able to participate:
The PREVUE study experience shows that we can design cardiovascular clinical trials that reach all affected populations now; leveraging a combination of technology and a distributed healthcare workforce to allow greater and faster reach with the highest standards of data quality.
This is just one example of what’s possible today, with many implications for not just how studies are designed and executed, but also how they can impact cardiovascular care. We’ll look at some of those implications in a future post.