Despite racial and ethnic minorities representing more than 40% of the U.S. population, their participation in clinical trials remains disproportionately low, often ranging from just 2% to 22%.
In response to these disparities, the FDA launched the "Enhancing Clinical Study Diversity" initiative in 2020 aimed at improving diversity in clinical trials. However, this program was discontinued following the Trump administration's broader policy to end diversity, equity, inclusion, and accessibility programs. Despite this, the importance of diversity in clinical research remains undeniable.
A comprehensive review of 167 new molecular entities approved by the FDA found that approximately 1 in 5 of these treatments had different effects on racial and ethnic groups. This underlines the necessity for ensuring that all demographic groups are adequately represented in medical research.
The 10 key strategies listed below will help you address the diversity gap and create more inclusive clinical trial participation.
10 Key Strategies for Increasing Diversity in Clinical Trials
1. Build Trust Within Underrepresented Communities
Historical mistrust of the medical system remains a significant barriers to trial participation, especially in Black and Hispanic communities. Concerns about the exploitation of minority groups in medical research continue to resonate, with many citing past abuses such as the Tuskegee Syphilis Study as reasons for their hesitancy.
The 1972 Tuskegee Syphilis Study where many Black or African American men with syphilis were left intentionally untreated for many years, has been correlated with increases in medical mistrust and mortality because of the fear of engaging in the health care system. To overcome this, clinical trial sponsors must take deliberate steps to build trust within these communities.
One effective strategy is collaboration with well-established and trusted community organizations, such as local churches, nonprofits, and advocacy groups. These organizations are often integral parts of the community and can act as intermediaries, helping to share trial information and alleviate fears. Additionally, providing safety and efficacy data from previous trial phases can help foster transparency and trust.
2. Train Research Site Staff in Cultural Competency
Unconscious bias can manifest in a variety of ways throughout the clinical trial process, from recruitment and patient interactions to eligibility criteria and referrals. The FDA has identified this bias as a key obstacle to inclusion, particularly given the legacy of mistrust stemming from unethical practices such as the Tuskegee Syphilis Study.
A more recent example of bias in medical research is the underrepresentation of Black patients in pain management studies, stemming from the false belief that Black individuals have a higher pain tolerance. This bias has led to fewer referrals for pain-related clinical trials and disparities in access to new treatments. To mitigate the impact of bias, clinical trial staff must undergo thorough cultural competency training. This training should cover a range of topics, including real-world case studies, implicit bias assessments, and methods for communicating clearly and respectfully with participants from diverse backgrounds.
In addition, employing blind screening methods - where participants are evaluated solely based on their eligibility criteria - can help minimize subjectivity in recruitment. Moreover, ensuring that informed consent materials are culturally appropriate and easily understood is crucial for fostering inclusivity and ensuring participants feel respected and valued.
3. Use Diverse Imagery and Patient Testimonials to Foster Inclusion
Representation is key in overcoming hesitations about clinical trial participation. The use of images depicting individuals from underrepresented communities in advertisements and outreach materials can play a pivotal role in building trust and reducing barriers. When people see others who resemble them participating in trials, they are more likely to consider enrolling themselves. Representation is not just about appearance; it is about sending a message that everyone, regardless of their background, deserves access to groundbreaking medical treatments. This approach helps to combat feelings of alienation or skepticism about the clinical research process.
Furthermore, featuring diverse patients in testimonials - both in text and video format - can help build trust and relatability among underrepresented communities. When potential participants see individuals from similar backgrounds sharing their positive experiences, they may feel more confident and reassured about joining a clinical trial. Authentic stories can also address common concerns, dispel misconceptions, and highlight the inclusivity of the trial, ultimately encouraging broader participation.
4. Offer Multilingual Outreach Materials
Language is often a substantial barrier to participation, particularly for non-English speakers. In 2021, research showed that non-English speakers were 30% less likely to enroll in cancer clinical trials than their English-speaking counterparts. To overcome this, clinical trial sponsors should provide outreach materials in multiple languages. Especially Spanish should be a priority as it is the second most spoken language in the United States, with about 42 million speakers, making up about 13% of the population.
Translating written materials is just one part of the solution - ensuring that staff can communicate effectively with participants in their preferred language is equally critical for building trust and improving retention. About a third of Hispanic adults prefer to see a Spanish-speaking doctor or health care provider and 81% of those who are Spanish language dominant.
5. Simplify Language in Patient-Facing Materials
Complexity in written materials can significantly discourage potential participants. Studies consistently show that 9 out of 10 people struggle to understand health-related information, especially when it is filled with technical language.
For this reason, even when materials are translated into a patient’s native language, jargon-heavy content can still be a barrier. For instance, when explaining trial protocols, risks, and benefits, it is essential to write materials in plain language that can be easily understood by a wide audience. A simplified, clear approach to communicating trial details ensures that potential participants fully understand what they are agreeing to and helps reduce anxiety and confusion about the process.
6. Expand Trial Site Locations and Offer Flexible Scheduling
Traditional clinical trial sites are often located in wealthier urban areas and typically operate during standard business hours, which excludes large segments of the population - particularly those from rural or underserved communities. To address this, clinical trial sponsors should consider expanding the geographic reach of their trials by establishing research sites in underrepresented regions. In addition, offering flexible scheduling options, such as weekend and evening appointments, can accommodate individuals with work commitments or family obligations.
7. Provide Financial Support and Transportation Assistance
Financial barriers are a significant obstacle to participation in clinical trials, especially for individuals from lower-income backgrounds. In 2023, the median income for Hispanic and Black households was $65,540 and $56,490 respectively. Meanwhile, the median household income for non-Hispanic White households was $89,050. This highlights disparities in income that may complicate participation.
Moreover, a significant percentage of Black and Hispanic households lack access to reliable transportation, which further complicates participation. To make clinical trials more accessible, sponsors should consider providing stipends to cover lost wages, childcare services for parents, and reimbursement for travel expenses or transportation services for those without reliable access to a vehicle.
8. Implement Decentralized Trial Elements
Decentralized clinical trials (DCTs) have emerged as a promising model to increase accessibility, particularly for individuals with mobility challenges or those living in rural areas. DCTs use remote monitoring, telemedicine, and at-home visits to minimize the need for frequent site visits. While fully decentralized trials often are not feasible and remain rare, using a hybrid-style trial and incorporating some decentralized elements into the trial process can still help reduce some of the burdens that come with frequent site visits. These approaches help overcome logistical challenges and expand access to a wider range of participants, ensuring that clinical trials better reflect the diversity of the population.
9. Continuously Monitor Diversity Metrics
Ensuring diversity in clinical trials requires a sustained effort. Sponsors should regularly monitor enrollment data by the chosen diversity metrics to track progress and identify any gaps. If certain groups remain underrepresented, adjustments in the recruitment strategies can be made to address these disparities.
10. Partner With a Patient Recruitment Agency
Patient recruitment agencies can offer valuable expertise in reaching underrepresented groups. Some patient recruitment agencies focus on developing outreach strategies tailored to diverse populations and can help clinical trial sponsors connect with individuals who might otherwise be difficult to reach. By partnering with these agencies, sponsors can access proven methods and insights to enhance their recruitment efforts and increase diversity in their trials.
At Patiro, we understand the importance of ensuring a diverse pool of participants that is representative to the total population. Patiro has collaborated with some of the largest pharmaceutical companies in the world and has helped enroll diverse patient populations in more than 44 countries across more than 2,000 diseases. Schedule a demo today to learn more about how we can help you increase clinical trial diversity.
Final Thoughts on Increasing Diversity in Clinical Trials
Achieving diversity in clinical trials is a complex challenge and requires a multifaceted approach that takes into account deep-rooted cultural, socioeconomic, and historical factors. However, by implementing intentional strategies - such as improving outreach, simplifying communication, building trust, and removing financial and logistical barriers - clinical trial sponsors can take meaningful steps toward fostering inclusivity.
A diverse participant pool ensures that new treatments are safe and effective for all populations, ultimately leading to better healthcare outcomes for everyone. Inclusion in clinical trials is not just a moral imperative; it is essential for advancing science and improving public health for all.
