Experts' Perspectives: How to Address a Lack of Diversity in Clinical Trials

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In the final part of our 3-part series, our panel of experts discuss what their fields and its leaders could do to make sure this lack of diversity in trials does not continue. These responses are highlighted in the following video and transcribed below.

In recognition of the close of Black History Month, the editorial staff of HCPLive interviewed clinicians of color across more than half a dozen specialties and asked how a lack of clinical trial diversity has impacted their specialties as well as the real-world care of patients. In this series, we posed our group of experts a series of 3 questions pertaining to the historic lack of diversity, how it manifests in today’s care, and what the future might look like if left unchecked.

In this portion of the series, we spotlight responses to our final question, which questioned what their fields and its leaders could do to ensure this lack of diversity in trials does not continue. These responses are highlighted in the following video and transcribed below.

For more from this series: Experts' Perspectives: How Lacking Clinical Trial Diversity Impacts Public Health

HCPLive: If the issue of diversity in clinical trials is not adequately addressed, how do you foresee it further influencing the future landscape of your specialty? What steps do you believe should be taken to ensure more inclusive and representative research practices for the benefit of diverse patient populations?

Nasrien Ibrahim, MD, MPH: I think the most important thing for me is that if we keep doing this, if we keep doing these clinical trials, and not making the extra effort to reach out to the patient populations that we're missing, so we're not putting in extra resources, and how we can reach more black patients, how we can reach more American Indian patients who are significantly underenrolled in heart failure trials, especially, it's just going to keep getting worse. We talk about inclusion and we keep publishing these papers and talking about it at committees and talking about it at conferences, but it's just going to keep getting worse if we keep talking and not putting in the resources and the efforts to say, 'Okay, how can we actually fix this problem?'. We're talking about this sense of feeling not included in science. So, how can these populations feel like they trust the healthcare system, they trust the scientific communities, and they want to be enrolled in clinical trials? If, number one, they're always underrepresented, represented. And, number two, we're not even putting in the resources to enroll them.

The second part of your question is, how do we do better? The biggest issue I see with clinical trialists is that in the middle of the trial, while it's already ongoing, they look at their numbers, and they're like, 'Oh, we haven't enrolled enough women, we haven't enrolled black patients'. Now you're trying to work backward and say, 'How can we make this better in the middle of a trial?'

I think the most important thing is that at the inception of the clinical trial, what efforts are you undertaking to make sure that you're enrolling a diverse population, which includes low income rural patients, not just your regular patient that is working a 9 to 5 and making a ton of money who is able to take time off work and come for several hours a week for a clinical trial? We just need to be more inclusive, and that needs to start at the inception of the trial? How are you thinking about this thing? What centers are you targeting to be part of your clinical trial? Where are they located? Are they located in urban neighborhoodsand what are their resources?

When we're looking at our centers, we can go to the usual powerhouses because they're well-resourced, but how about going and providing the resources to centers that we don't normally use and have them trained or provide them the resources so that they can become part of the clinical trial landscape and enroll the patient populations that we want to enroll? Of course, the usual things that we talk about all the time, who's on your steering committee, who was leading these trials, who were the principal investigators—that needs to change. I am sick and tired of hearing us keep talking about it and hen you go to these big meetings and you see who's on the stage presenting these trials and nothing has changed over the last few years.

Ashwin Ananthakrishnan, MD, MBBS, MPH: I find it reassuring that across society, clinical trials, and the medical community, there's a growing recognition of the critical importance of diversity in all aspects of our work, from studying medicines to delivering care. Acknowledging the gaps and challenges related to the lack of data and diversity is an essential initial step. Moving forward, it's crucial for our field to address these issues comprehensively.

There are various actions that can be taken to enhance diversity in clinical trials. This includes ensuring that trial sites are accessible to racially and ethnically diverse populations, potentially requiring translations into different languages, and considering the social determinants of health that may affect access to trials in different communities. Attention should be given not only to recruitment strategies but also to trial design, considering how the demands placed on participants may differ across racial and ethnic groups.

Merely opening trial sites in underrepresented areas is not sufficient. It's essential to take a multidimensional approach and carefully consider the diverse needs and circumstances of potential participants. Racial and ethnic diversity is undoubtedly a significant challenge, but it's not the only aspect of diversity that requires attention.

For example, there is also underrepresentation of older adults in clinical trials, despite the aging population. Similarly, there may be disparities in access to trials between rural and urban populations. Thus, it's essential to broaden our perspective and address diversity across various dimensions to ensure that clinical research reflects the full spectrum of patients who will benefit from these treatments.

Maya Clark-Cutaia, RN, MSN, PhD: My concern is that without better representation in clinical trials, we risk widening the gap in outcomes between those who are represented and those who are underrepresented. While I am encouraged by the current conversations and growing interest in this issue, I believe we need to take further steps in how we approach patient recruitment and engagement. It's essential to educate patients on the importance of participating in clinical trials and to provide support and guidance to ensure their involvement.

Moreover, as clinicians and researchers, we must undergo training to develop cultural humility and sensitivity. This includes understanding the unique needs and perspectives of diverse patient populations and addressing structural and systemic racism within healthcare systems. For example, recent studies on access to kidney transplants have highlighted the significant impact of structural and systemic racism on patient outcomes, alongside the barriers to participation in clinical trials.

It's crucial to recognize that we are only beginning to scratch the surface of this issue. Many of us may feel uncomfortable discussing topics related to structural racism and systemic inequities, but it's imperative that we embrace these uncomfortable conversations. Only by acknowledging and addressing these challenges can we work towards creating a more inclusive and equitable healthcare system for all.

Luisa N. Borrell, DDS, PhD: I have some hope with the All of Us study by the NIH, which aims to enroll a million participants and is showing promising diversity reflective of the U.S. population. However, a limitation is that it may not fully represent underserved communities as it relies on hospitals willing to participate. Nonetheless, the study includes a wide range of data, including generics, connected to electronic records, offering potential for precision medicine research. This vast dataset allows principal investigators to recruit participants and track their information, regardless of where they seek care.

If we are serious about advancing precision medicine, we must prioritize diversity and consider the lived experiences of each individual. Additionally, epigenetics plays a crucial role, as environmental factors can influence genetic makeup and impact health outcomes. These factors, whether reversible or not, underscore the complexity of precision medicine and the importance of comprehensive data collection and analysis.

Leesha Ellis-Cox, MD, MPH: Certainly, if we don't address these issues, improvements in treatments may stagnate or fall short. To address this, several key steps could be taken. Firstly, it's important to assess the diversity of investigators involved in research projects. Often, investigators may not reflect the racial and ethnic diversity of the populations being studied. Similarly, the staff responsible for communicating with potential participants may not represent the diversity of the community. Ensuring a diverse team that can effectively engage with patients is crucial.

Moreover, it's important to prioritize understanding the health concerns and priorities of communities of color. Rather than solely focusing on research topics deemed important by academic centers, efforts should be made to actively listen to the needs and preferences of these communities. Building partnerships based on mutual understanding and respect can foster greater engagement from the African American community and other underrepresented groups in research studies. Addressing practical barriers such as transportation is also essential. Providing resources for study participants who may face challenges in accessing clinical sites can significantly improve participation rates. Additionally, evaluating the health literacy of materials used for informed consent and study information is vital to ensure comprehension and empowerment among participants.

Ashira Blazer, MD, MSCI: I believe our population is incredibly diverse, reflecting the United States as a melting pot. Therefore, if we fail to include patients from all backgrounds in our clinical trials, we won't be able to find appropriate solutions. Additionally, many of the drugs we use have exclusion criteria for clinical trial participation, such as being on certain medications. Consequently, the same population gets enrolled in trials repeatedly, leading to a shrinking pool of potential participants and hindering future discoveries.

It's crucial to ensure equitable access to healthcare for all individuals, as those without access also lack access to clinical trials. Improving health equity is essential, as consistent care is a prerequisite for trial participation. Furthermore, transparency in the healthcare system is vital, given its historical issues of trustworthiness, particularly among ethnic communities facing discrimination. Culturally competent care is equally crucial, yet our healthcare system lacks diversity, often resulting in a disconnect between physicians and patients.

While diversifying the physician population will take time, engaging allied health professionals and patient advocates can aid in educating communities about clinical trials. Additionally, involving non-physician providers in trials can extend reach to communities beyond large healthcare networks. These steps are essential to ensure inclusivity and accessibility in clinical research.

Girardin Jean-Louis, PhD: In my field, which focuses on sleep insecurity and sciences, significant efforts have been made over the past 20 years. The number of scientists addressing these issues has notably increased, resulting in a corresponding rise in publications. This heightened awareness has shed light on the impact of sleep insecurity on long-term outcomes, such as cardiovascular disease and brain health, particularly dementia. While progress has been made, achieving health equity for all communities remains a work in progress.

We are beginning to understand the direct connection between poor sleep and cardiovascular disease, as well as brain health. Efforts are underway to explore potential interventions to reduce disparities. For instance, ensuring that black and Latino individuals can attain the recommended seven to eight hours of sleep per night, as advised by the Academy, could lead to reductions in cardiovascular disease risk. While we have not yet reached this goal, it remains our objective to develop solutions that directly address these disparities, allowing all communities to benefit equally.