Apr 27, 2023

The Role of Community Healthcare in Improving Research Participation and Health Equity

Developing and gaining approval for new drugs and medical devices requires following a regulated and controlled clinical trial process. Government laws provide the necessary pathway to ensure new treatments are safe and effective for patients. In the United States, we conduct clinical trials for all new therapies before being approved by the Food and Drug Administration (FDA).

Safety is a priority for clinical trial design. Once considered safe, we monitor for efficacy and assess this within the targeted disease. Many factors, including race, gender, age, ethnicity, geography, and even socioeconomic conditions, can impact the safety and effectiveness of the treatment. For example, heart diseases, stroke, cancer, asthma, influenza, and pneumonia affect African American more than Caucasian populations. And yet, historically, diverse representation has not been a fully inclusive consideration or requirement when recruiting patients for clinical trials.

 

Recent efforts over the past decade to provide access to clinical trials within community healthcare have led to improvements and understandings of clinical research. Trust, location, and geography are important in whether a patient agrees to participate in a clinical trial.

Recommendations from Trusted Healthcare Advisors
Patients who receive recommendations from their healthcare advisors could be more likely to participate in clinical trials and learn about them as a viable care option. Consider the patients who trust the advice of their healthcare providers and are more open to exploring new treatment options when recommended by someone they have previously relied on to provide them with healthcare recommendations.

Reduced Burden of Participation Due to Location
Conducting clinical trials at community sites reduces the burden of participation for patients. By offering clinical trial opportunities at locations where patients already receive healthcare, it becomes more manageable for them to comply with the study's requirements, which can include multiple site visits. This convenience helps increase participation and ensures a more diverse pool of trial participants.

Community Research Sites and Historically Underrepresented Populations
Community research sites in geographic areas with historically underrepresented populations, including racial, ethnic, gender, age, and socioeconomic groups, can reach people often excluded in trials. These populations represent the patients affected by the diseases that the treatments mean to help. By conducting clinical trials within these communities, researchers can increase the representation of these groups in their studies, leading to more accurate and applicable results.

 

Beyond the considerations of trust, location, and geography to improve participation in clinical research, community research can improve health equity. If we do not improve health equity, there are substantial adverse effects.

We can improve overall health equity by increasing the representation of historically underrepresented populations in clinical trials through community-based research in several ways, including:

  1. Strengthening Relationships
    Clinical trials in a community healthcare setting can further strengthen relationships between medical professionals and local patients. Sharing these opportunities expands knowledge about clinical trials to patients who historically have not learned about or understand their value and provides these treatment options to doctors treating patients in communities. Ultimately, physicians seeking to provide new patient care choices can do so with clinical trials.
  2. Enhancing Generalizability of Clinical Research Results
    Improved representation of diverse populations in clinical trials helps ensure that results are more generalizable. This approach means that the findings from these trials can be more confidently applied to a broader range of patients, leading to improved healthcare outcomes for everyone.
  3. Fostering Innovation
    Researchers conducting clinical trials within diverse communities can study a broader range of patient characteristics and treatment responses. This approach can lead to new insights and innovations that might not be discovered in a more homogeneous population.

 

On the other hand, a lack of representation in clinical research can have several negative consequences  on population health and medical care, including:

  1. Undermine Certain Groups' Trust in Medical Professionals

When clinical research does not include certain underrepresented groups, it can lead to distrust in medical professionals among these populations. This distrust can result in a lack of willingness to participate in clinical trials, perpetuating the underrepresentation cycle.

  1. Compromises the Generalizability of the Trial's Results
    The results may only apply to a broader range of patients if a clinical trial has a diverse participant pool. This lack of generalizability can limit the usefulness of the research findings in guiding treatment decisions for patients from different backgrounds.
  2. Hinders Medical Innovation
    A lack of diverse representation in clinical trials can stifle medical innovation. When researchers can study a wide range of patient characteristics and treatment responses, they may take advantage of crucial insights that could lead to new, more effective treatments.

 

By prioritizing clinical research participation in community healthcare, we can work towards a more equitable and inclusive healthcare system that benefits everyone. The value of community research sites in helping to solve many challenges faced by clinical researchers and healthcare providers is apparent. Reducing the burden of participation and improving diverse representation can lead to better health equity overall, starting with clinical trials that reflect those impacted by the diseases and conditions the treatments should help.