Diversity in clinical trials is not merely a regulatory checkbox but a critical component of ethical and effective medical research. The historical underrepresentation of certain groups, particularly Black, Asian and other ethnic minorities in clinical trials, poses ethical and scientific challenges. It limits the understanding of how different populations respond to treatments, which can exacerbate health disparities. Regulatory bodies like the US Food and Drug Administration (FDA) have recognized the importance of diversity in clinical trials and recently issued guidance to improve inclusivity.
However, the FDA’s latest guidance also highlights that diversity must be understood in a broader context. It is not limited to racial and ethnic representation but also includes socioeconomic factors that can influence health outcomes and access to clinical trials. This shift recognizes that individuals from different socioeconomic backgrounds may experience unique barriers to participation in clinical research. As such, the FDA is now encouraging sponsors to consider factors such as site locations and community-based care to facilitate greater participation from diverse populations.
The campaign for diversity, equality and inclusion (DEI) has become a key focus of legislation not only by the FDA, but also by other global regulatory bodies. In the future, clinical trial data may be required to establish a medication or biologic’s safety and effectiveness in numerous different subgroups.
Building trust
Diversity in clinical trials is essential for building trust within communities and improving public confidence in clinical research. A UK poll by YouGov revealed that 88% of respondents believe diversity in health and social care trials is crucial. The survey, commissioned by the Health Research Authority, found that 91% of people consider diversity important, even if it incurs more costs and slows down the research process, with over half saying they would feel more confident in results if they knew they came from diverse trials.
Thad Wolfram is president of EmVenio Research, a PCM Trials company that is focused on the growth of hybrid and decentralized trial capabilities with the aim of increasing clinical trial diversity and inclusion.
“First, we have to consider communities as a whole – how do we build trust in areas where trust may be lacking?” asks Wolfram, speaking on a panel discussion in October on the integration of social determinant of health (SDOH) data in clinical trials to improve recruitment and retention.
“While distance [from the trial] is certainly a burden, it’s also worth considering what other challenges they face? What are the risks in the community and how can we help address them?” he says. Education about healthcare and clinical trials are critical aspects of engaging communities, says Wolfram, as well as addressing challenges such as food insecurity and housing instability, which can significantly impact a patient’s ability and willingness to participate in a trial but are often not well-accounted for in trial design.
“By combining these challenges, we can engage these communities and make it easier for them to participate in research. By doing so, we can be valuable members of these communities and contribute to their well-being,” he says.
Collecting the right data
Traditional clinical trial data tends to be siloed and focused only on clinical measures, without incorporating the broader social, economic and environmental factors that can influence patient health and trial participation. However, the importance of incorporating non-traditional data sources, such as SDOH, into clinical trials, can give researchers a more comprehensive understanding of the patient populations they are trying to recruit and retain. Insights from SDOH can help identify and address specific barriers that may be preventing underrepresented patients from participating in clinical trials, such as transportation challenges or financial constraints.
Ryan Moog is head of Life Sciences Solutions at Datavant, with over 15 years of experience working in strategy and product leadership roles in support of clinical innovation and real-world evidence generation. He says that a lot of this data is already available, but not in a form that is consolidated to inform future clinical trial design.
“There’s an opportunity here to really learn,” says Moog. “That’s reflected in the latest draft guidance on diversity action plans from the FDA, where the verbiage has shifted from underrepresented racial and ethnic populations, to underrepresented populations – in recognition of the populations who are underrepresented in trials, like women, pregnant women, older patients, pediatrics.”
But while you can ask for patients’ information about their general location and what their home life looks like, it often doesn’t represent that patient’s full story, says Moog.
Building up the patient’s story is something that Dr Trenor Williams has been working on as CEO and co-founder of Socially Determined, an analytics platform that integrates SDOH with clinical and claims data to quantify and visualize social risk and the specific impacts on health and healthcare outcomes. Socially Determined’s goal is to boost diversity in trials as well as recruitment and retention. Williams says that far too many clinical trial populations do not look like the patients that they ultimately seek to benefit.
“Even if you’re just thinking about it from a manufacturer standpoint, as you migrate towards more precision medicine, if the participant pool that you are working with doesn’t mirror the people that you actually want to be able to take your drugs down the line, that’s a massive business mismatch. It takes all types of data – we use 40 different sources of open public data,” says Williams.
By looking at where healthcare facilities are, grocery stores and fast-food restaurants, you can build up a more detailed picture of so-called food deserts and food swamps, says Williams. Add to this consumer and financial data on 250 plus million individuals across the US – including estimated household income and car ownership – and you can start to create a more holistic view of a community and establish what challenges, burdens and barriers that an individual, family or population may face.
Bringing clinical trials into communities
EmVenio Research, a PCM Trials company, brings all of this data together to create solutions for more equitable and representative clinical trials. First was to establish community-based research sites that are embedded within the local communities they serve. EmVenio has been working in partnership with Socially Determined, analyzing social determinants of health to help choose the locations for its mobile sites, providing a network across the US and UK.
Thad Wolfram says this also allows EmVenio to better understand the specific needs and challenges of those populations and tailor their engagement and support accordingly. He emphasizes the significance of localization by hiring locally, ensuring research teams are culturally sensitive and empowering them to engage with the community. An example of this was a team in Arkansas who proactively helped the broader community after a tornado, showing the importance of giving back to the local citizens.
“It’s important to remember that no two communities are alike,” he says. “How do we go in and reflect the local community back to them? How do we engage them in a way that is reflective of how they want to be treated and thought about? It’s necessary to have these types of insights to really understand and to be able to build trust. That’s the precursor to enrollment but also retention, because it really carries through before, during and after a clinical trial – the way that you understand the community and how you’re going to engage with them.”
Utilizing non-traditional data sources in clinical trials ensures participants are representative of the broader patient population, enabling researchers to design therapies better suited to real-world patient needs and ensuring that new therapies are effective and accessible for all patient populations, not just those who are more typically represented in clinical trials.
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