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Diversity in Clinical Research: Overcoming Barriers to Minority Participation

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Clinical research drives medical advancements, but its success relies on the voluntary participation of a diverse population. Recruiting participants, especially from minority groups, remains a significant challenge. Addressing this imbalance requires understanding and overcoming both patient-related and institutional barriers. Many minority groups have limited access to clinical research due to a lack of awareness, socioeconomic challenges, and historical mistrust of the medical community. Additionally, under-resourced facilities and narrow inclusion criteria further exclude these populations. Achieving true diversity in clinical research necessitates a collaborative effort from all stakeholders. Providers, sponsors, and participants must work together to create inclusive and accessible research environments. At PatientWing, we are dedicated to advancing this mission. Continue reading to learn more about how we can help achieve your diverse enrollment goals.

An Overview of Clinical Research for Healthcare

Clinical research is a vital part of scientific investigation aimed at preventing, diagnosing, and treating illnesses. It involves human participants and collects evidence to develop guidelines and best practices, shaping the standard of care for various medical conditions. The success of these studies relies entirely on voluntary participants. By taking part, individuals can actively engage in their own healthcare, access new research treatments, explore additional treatment options when existing ones have failed, receive care at top healthcare facilities during the study, and, most importantly, contribute to the advancement of medical knowledge. [Source]

Although clinical studies are at the core of healthcare advancements, recruiting study participants is difficult. Some reports state that up to 85% of clinical studies fail to recruit or retain enough participants to complete a study successfully [Source]. Additionally, recruiting racial and ethnic minorities for clinical studies has been largely ineffective. Currently, African Americans represent only 15% of minority participants, while Hispanics account for just 7.6% [Source]. In contrast, White individuals make up the vast majority of study participants. This imbalance affects the applicability of treatments to the diverse U.S. population and hinders targeted clinical findings for minority groups.

How are Minority Groups Identified?

While the ethnic background in the United States continues to change, the term ‚Äúminority‚ÄĚ is most commonly used in reference to four major racial and ethnic groups: African Americans, American Indians and Alaska Natives, Asians and Pacific Islanders, and Hispanics. ¬†

Since the 2010 U.S. Census, the White non-Hispanic population has declined by nearly 6%. At the same time, the Hispanic population has grown significantly, now making up 18.7% of the U.S. population and becoming the second-largest demographic group in the country. Following closely, Black or African American alone non-Hispanic individuals account for just over 12% of the population.

Increasing minority participation in clinical research is crucial for developing and understanding new therapies. Certain technologies and treatments may not be effective for people from different racial and ethnic groups, or they may cause adverse reactions in specific populations. While race and ethnicity have been central to inclusion efforts, true diversity in clinical studies extends beyond these categories. Factors such as sex, sexual orientation, age, socioeconomic status, geography, and education also play crucial roles in determining the availability and applicability of therapies. By considering these elements in clinical research, we can ensure a more comprehensive and effective approach to healthcare.

The following section highlights some of the barriers that minority populations face in clinical study participation.  

Keep reading to learn more and see where you can support!  

Minority Patient Related Barriers

Many factors affect people's decision to participate in clinical research, including personal values and systematic barriers. These can be separated into patient-related and institutional barriers.

Patient-Related Barriers


Access to clinical research presents a significant barrier for many minority populations. This barrier can manifest in multiple ways in diverse communities.  

The first access barrier to clinical study participation is knowledge and education about the clinical study process. Many groups may misunderstand the clinical study process and their role, impact, and rights throughout it.  

While increasing education about the clinical study process is critical to bridging these gaps, offering this in a culturally sensitive and understandable language is essential to build trust. For example, translating study educational material into minority languages would help communicate to certain demographics but does not address illiterate populations in those communities. Additional efforts are necessary to educate minority groups and address fears or hesitations with the clinical study process.  

Another barrier to clinical research participation in minority groups is socioeconomic status. Compared to White non-Hispanic groups, Blacks and Hispanics are often associated with a lower socioeconomic and educational level. Clinical study participants are historically more likely to be employed, insured, and have a higher income. [Source] While the reasons for this socioeconomic disparity are plentiful and require careful analysis, the reality is that participants with lower socioeconomic status are less likely to participate in a clinical study due to the hidden participation costs. These include costs associated with traveling to and from appointments, the need for extra childcare, and any loss of income due to missed work. [Source] Therefore, clinical study sponsors should carefully consider how their study is inclusive to minority groups by addressing hidden costs of study participation.  

Mistrust in Minority Populations is a Unified Effort

Trust in the medical community has been in a downward trend over the past few decades [Source]. While this medical mistrust has multiple causes, it has been previously exacerbated by past ethical breaches in the medical community. Additionally, community-based experiences and/or identity-based discrimination against some participants have fueled mistrust in many communities. In particular, African Americans are notably hesitant to participate in clinical studies as a result of centuries of medical abuse and discrimination that caused understandable mistrust. Today discrimination and bias in the healthcare system towards African Americans is still largely reported throughout the community. [Source] A unified effort to build trust with minority participants that includes the entirety of their healthcare team is essential to strengthen relationships and improve medical care equitably.

Institutional Barriers

Under-Resourced Facilities

The financial costs of enrolling and running clinical studies are significant, and they disproportionately affect minorities who are more likely to be underinsured and seek care at under-resourced facilities. These facilities often lack the resources to conduct relevant clinical studies, limiting access for patients who cannot travel outside their local network. However, these networks are ideal for conducting studies since they have built trust with these populations and would enable participants to own their care journey within their community. Additionally, running studies locally would reduce participation costs, as the patients travel would be reduced.

Underinsured and I/E Criteria

In addition, underinsured patients often lack access to state-of-the-art procedures, leading to undiagnosed conditions or untreated comorbidities. Due to narrow inclusion and exclusion criteria, these complications frequently exclude them from participating in studies. By understanding the institutional barriers that minority populations face, sponsors and care teams can revisit site locations to be more inclusionary to minority populations, provide diagnosis and treatment support throughout the study, and thoughtfully adjust criteria to avoid exclusion of relevant minority groups.  

Is There a Solution for this Complex Issue?

While race and ethnic disparities have created significant barriers for minorities in clinical research participation, including these populations is essential for the application of future healthcare outcomes. Achieving lasting and impactful solutions requires effort from all stakeholders to work purposefully towards equitable and diverse inclusion in clinical research. Although awareness of these issues has increased, supported by recent FDA guidance on diverse enrollment, much work remains. Providers must assess their organization’s current state and implement appropriate changes at each institutional level. Sponsors should proactively involve patient input and thoughtfully develop their protocols, and patients should become advocates for their individualized healthcare. By each doing their part, we can move towards a future where healthcare achieves its true purpose of providing better care for all.

How Can PatientWing Help?

At PatientWing, we understand the importance of patient diversity and offer a comprehensive enrollment solution to make your study more inclusive. Our holistic approach ensures that minority patient populations are reached and included in your clinical study, helping you achieve your diverse enrollment goals.

We start by analyzing the demographics of the disease population and devising appropriate strategies for your specific study. Our main steps are outlined as follows:


  • We proactively engage community organizations to gather perceptions and feedback on clinical research from minority groups.
  • The use of geo-targeted advertising in areas near research sites where minority populations are highly represented helps us gather relevant participants that have a higher participation interest.

Participant Engagement

  • We identify and interview diverse patients with the condition to understand their personal experiences and their community's perspective.
  • By raising awareness through relationships with community, civic, and faith-based organizations, involving leaders, educators, community influencers, and local businesses such as barbershops, beauty salons, restaurants, and recreational facilities, we help establish the study‚Äôs presence and build lasting ties between participants and sponsors.

Recruitment Methods

  • We support patients, caregivers, and their loved ones and alleviate concerns associated with clinical research participation.
  • We assist research sites throughout enrollment by facilitating patient medical records, directly scheduling patients for prescreening appointments at research sites, and conducting patient re-engagement.

Connect with us (www.patientwing.com/contact)  today for a complimentary patient enrollment impact assessment for your study and learn how we can help you achieve your diverse enrollment goals!

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