October 25, 2024 | In clinical research, one ongoing challenge continues to persist: a lack of diverse representation. While the root cause stems from a combination of limited access and endemic mistrust of the health care system among certain communities, the outcome is that large pockets of communities are often excluded from studies, even in key areas where they are disproportionately affected by diseases such as diabetes, heart disease, and certain forms of cancer.
However, new strategies are emerging to address this imbalance. Community-based approaches in clinical trials are paramount to bridging this gap and paving the way for more inclusive and effective healthcare solutions.
Understanding the Problem
The underrepresentation of diverse populations in clinical research is not just a matter of statistics. It means that certain communities may not fully benefit from medical advancements. For example, while African Americans represent about 13% of the U.S. population, they make up less than 8% of clinical trial participants. The consequences are clear: treatments may not be as effective for the populations not adequately represented in the research studies.
True health equity can only be realized in healthcare when relationships within the communities in question are established and nourished on an ongoing basis; just showing up once when an investigator need them to join a trial is a recipe for continued failure. Many communities, such as Black/African American, Hispanic/Latino, LBTQ++, American Indian/Alaska Native (AIAN), and Asian American and Pacific Islander (AAPI), face barriers to healthcare access and participation in clinical trials.
There are many reasons why underserved communities do not participate in clinical trials, but mistrust of pharmaceutical companies and healthcare providers, driven by historical injustices such as the treatment of Henrietta Lacks and the participants in the Tuskegee Syphilis Study, plays a significant role.
To address this issue, many research institutions are engaging local organizations and stakeholders to institute a community-based approach to improve awareness, education, trust, and ultimately participation in clinical studies.
The Role of Policy Makers
On June 26, 2024, the FDA provided guidance urging pharmaceutical companies and researchers to prioritize diversity with programs like the Diversity Action Plan (DAP). This approach helps to enrich the data collected, ensuring a more comprehensive understanding of how the treatment affects various patient populations. Increasing diversity in these studies helps gain deeper insights into the disease or therapy being examined to ensure that results are more broadly applicable.
Barriers to Diverse Participation in Clinical Studies
There are significant barriers that pharma companies must overcome when recruiting participants from underrepresented communities including cultural mistrust, potential language differences, and facilitating shared dialogue between healthcare providers and patients.
In addition, many minority populations face financial constraints, lack of reliable transportation and limited access to healthcare facilities. It can be difficult to attend appointments during work hours or find childcare during their appointment time. While solutions such as transportation services, patient payment solutions, and at-home nursing options can help mitigate these challenges, accessibility for these communities must be considered when the protocol is developed.
The Importance of a Community-Based Approach
To overcome these barriers, targeted solutions are needed to engage communities with healthcare education well before recruitment, address historical mistrust in medical research, and partner with culturally competent organizations. Tailoring interventions to community needs and working with trusted organizations can improve health literacy and reduce health disparities. It is also imperative to provide authentic, culturally relevant educational content, tools, and resources that speak to each unique community to bridge this gap.
When done right, these efforts can improve recruitment and increase retention rates, ensuring the representation of diverse populations.
Strategies for Implementing Community-Based Approaches
Effective strategies include:
- Partnering with credible local organizations who have roots in the community
- Utilizing community-based participatory research approaches
- Hosting informational sessions and micro-workshops in trusted community spaces like churches, community centers, hair salons
- Providing digital, video and print educational materials that are culturally relevant, easy to understand and actionable
Medical terminology is often overly complicated, and impossible to understand. A critical aspect of a successful community-based strategy is working with a specialized medical communication organization to create customized print, digital, and video content that is relevant, easy to understand, and practical.
Importance of Selecting Community-Based Trial Sites
Even when patients in an underrepresented community are properly educated on clinical trials and interested, it is often difficult for them to participate if there is not a trial site nearby. Establishing trial sites within the community and providing weekend or after-hours appointments can make participation significantly easier for these patients.
Diversity training for healthcare providers and site coordinators and inclusive educational resources can empower site staff to engage with patients from underserved communities. Employing principal investigators who reflect the community demographics is another way to help patients feel more comfortable in a clinical setting.
The Path Forward
If we are to create a healthcare system that truly serves everyone, clinical trials must reflect the diversity of the population. Community-based models are proving to be a powerful tool in achieving this goal, ensuring that medical advancements are informed by those who need them most. By investing in local engagement, addressing common barriers, and building trust, the medical community can take meaningful steps toward a future where access to clinical trials truly is equitable. The hope is that more communities will benefit from medical research, improving health outcomes, and narrowing the gaps in healthcare access and quality.
