Building Effective Diversity, Equity, and Inclusion Strategies in Clinical Trial Recruitment

Understanding DEI in Clinical Trials

DEI stands for Diversity, Equity, and Inclusion. In the context of clinical trials: 

Diversity refers to the inclusion of all types of people, encompassing different races, ethnicities, genders, ages, and socioeconomic status. 

Equity focuses on ensuring fair treatment and opportunities for everyone while striving to identify and eliminate barriers that prevent the full participation of individuals and groups in clinical trials. 

Inclusion entails creating environments where any individual or group feels welcomed, respected, supported and valued, motivating them to participate fully.¹  

Why is DEI so important in Clinical Trials?

Historically, the clinical trial participant population has not been reflective of individuals in the real world. Clinical trials have primarily enrolled white male patients, with consistent underrepresentation of the elderly, but especially certain racial and ethnic groups.² In fact, whilst racial and ethnic minorities make up 39% of the U.S. population, these groups represent only 2% to 16% of patients in clinical trials.² For example, in 2020, among 32,000 individuals who participated in new drug trials in the U.S. in 2020, only 8% were Black, 6% Asian, 11% Hispanic, and 30% were age 65 and older, showing significant underrepresentation of these important demographic groups.^3,4 

This disparity has substantial consequences: 

– Scientific validity. Factors such as age, biological sex, disabilities, race and ethnic background may influence how an individual reacts to a certain drug or medicinal product.  

In fact, an individual’s likelihood of developing an adverse drug response (ADR) is dependent on genetics, epigenetics, and environmental factors, all of which vary across racial and ethnic populations.⁵ For example, warfarin, a widely prescribed anticoagulant for preventing thrombosis and embolism, exhibits significant differences in response among different populations. In fact, among patients with atrial fibrillation, Asians, Latinos, and African Americans have higher risks of developing warfarin-related intracranial hemorrhage than individuals with European ancestry.^6,7  

Therefore, a lack of diverse representation in clinical trials can compromise the scientific results, making it challenging to get a complete picture of a drug’s safety and efficacy across different populations. 

– Economic implications. “Low diversity costs money” 

ADRs have an estimated cost of $30.1 billion annually in the U.S.⁸ 

Low diversity in trials can lead to unexpected ADRs in underrepresented groups, resulting in additional and expensive medical costs. Furthermore, clinical trials that do not properly represent the population pool are at risk of approval rejections, leading to costs in the millions. 

In 2022, the Food and Drug Administration (FDA) rejected the approval of sintilimab in the U.S. The primary reason was that Eli Lilly’s phase 3 trial for sintilimab was conducted in China, primarily involving national participants. Consequently, the FDA panel found it challenging to determine how the safety and efficacy results would apply to the U.S. population, racially diverse from the Chinese population.  As a result, the FDA panel recommended Eli Lilly to conduct a new, more representative trial, with an estimated price tag of hundreds of millions of dollars above the original research costs. ^9,10    

Regulatory landscape 

DEI in clinical research will be no longer a moral imperative but a regulatory requirement.  

The FDA’s guidance documents Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry (here) and Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (here) propose regulatory strategies that clinical trial sponsors can utilize to enhance data for populations underrepresented in clinical research.^11,12   

Importantly, the current draft FDA guidance stipulates that clinical trial sponsors should provide data on the safety and effectiveness of drugs and biologics across gender, age, and racial subgroups. The guidance also suggests that the FDA will exercise its authority to ensure that relevant subpopulation data is collected.   

Failure to adequately represent diverse populations in ongoing or future clinical trials may delay product approval or result in the rejection of a new drug or device. 

Although the European Medicines Agency (EMA) currently has less stringent requirements for diversity in clinical trials, the advantages of adopting comprehensive DEI practices in Europe are evident. Beyond enhancing scientific validity and fulfilling ethical obligations, proactively integrating DEI strategies ensures that European companies are not caught off guard by new regulations, thereby avoiding costly delays and compliance issues. 

Barriers to Recruitment of Underrepresented Patients in Clinical Trials 

Several factors hinder the participation of underrepresented groups in clinical trials: 

1. Study Design

Unintentionally, restrictive trial criteria can be responsible for excluding individuals from diverse groups. In fact, Black patients have higher ineligibility rates (24%) than White patients (17%). Interestingly, Asian patients have the lowest ineligibility rate (12%) among all racial subgroups.^13,14  

These inclusion and exclusion criteria are designed to select patients with minimal underlying health conditions to ensure clear and straightforward analysis of results.^15,16 However, due to significant health disparities among different racial groups, these criteria may unintentionally exclude marginalized populations. For example, Black patients are more likely to be ineligible for cancer trials due to failure to meet hematology laboratory criteria. This is partly because normal neutrophil counts are naturally lower in Black people compared to White people. Additionally, anemia is also more common in Black patients with multiple myeloma than in White patients.¹³ These exclusions contribute to the underrepresentation of certain populations in clinical trials, potentially leading to biased results and less effective treatments for these groups.

2. Geographic barriers

Clinical trial sites are generally clustered in urban areas and large academic centers. Consequently, many communities, including minority groups or people living in rural areas, do not have easy access for study visits and follow up. This geographic distribution of research sites can hinder participation among underrepresented minority groups who do not live in close proximity to a clinical trial site, potentially leading to biased results and less effective treatments for these excluded populations.⁴

3. Socioeconomic barriers

These barriers include financial and time-related burdens, such as the costs of cancer treatment and medication, transportation, childcare, lost work, and inadequate or non-existent insurance. These challenges are more pronounced in specific racial and ethnic groups, who often report being primary caregivers to family members and lacking time to participate in clinical trials. They are also more likely to work in service occupations where it is difficult to get paid time off from work and to have more difficulties paying for health care, transportation, and other costs related to trial participation.¹⁷  

4. Information barriers

Clinical trial databases, such as clinicaltrials.gov can be difficult to navigate and are not patient user-friendly. This issue can be further exacerbated by poor health literacy among some individuals, preventing patients from understanding the information and lowering the likelihood of trial enrollment.¹⁸ In fact, a survey in eight European countries found that at least 1 in 10 respondents had insufficient health literacy, with higher rates among those who are financially deprived, less educated, or of lower social status.¹⁹ As a result, patients struggle to find and comprehend information relevant to their needs. This barrier can discourage patient participation in clinical trials, resulting in reduced diversity and representation in study populations and potentially compromising the generalizability and effectiveness of research findings. 

5. Language Barriers

Language barriers significantly hinder non-English speakers’ participation in clinical trials. In the U.S. and Europe, not being able to speak or read English is a major obstacle.¹⁴ For example, a retrospective study found out that patients with limited English proficiency were 3.4 times less likely to participate in gynecologic oncology trials than fluent English speakers.²⁰ Additionally, understanding the language is also critical when discussing informed consent, study protocols, and adverse event reporting.^21,22 

Some studies may also involve complex surveys, or questionnaires, which necessitate language proficiency to comprehend and interpret the questions.²² 

The consequences of patients being inadequately informed about medical procedures include low patient satisfaction with care, increased patient regret, and poor adherence to treatment plans.²³ Participants who do not understand how or when to report adverse events may not report them accurately or timely, leading to unaddressed health risks and severe consequences for their safety.²⁴ Negative experiences due to these barriers can discourage future participation.  

6. Trust and engagement

Despite its importance, community engagement often falls short when supporting the effective recruitment of underrepresented individuals. Trust is an underlining principle of community engagement.  Although many individuals may be amenable to participation in clinical trials, others have expressed fear of mistreatment, exploitation, and unintended consequences when approached for trial participation. These concerns are magnified in specific groups, particularly due to historical abuses, such as the Tuskegee Syphilis experiment and the unauthorized use of Henrietta Lacks’ cells, among other ethical violations.⁴ 

7. Diversity in research teams

While it has been observed that patients are more likely to participate in clinical trials when they share a similar background with the researchers, racial and ethnic minorities are also underrepresented among clinical trial investigators. In fact, a study showed that, among 600,000 full-time faculty at academic institutions, less than 5% were African American, 3% Hispanic, and 1% Native American.⁴  

Moving Forward 

Implementing effective DEI strategies in clinical trial recruitment is essential for scientific accuracy, economic efficiency, and ethical integrity. By targeting patient recruitment efforts where ethnic minorities live, partnering with community hospitals, addressing barriers to clinical trial participation and enhancing diversity among trial participants and researchers, the biopharma industry can ensure more comprehensive and reliable research outcomes, aligning with FDA guidelines and avoiding costly delays and compliance issues.  

myTomorrows strives to help make clinical trials more accessible and inclusive. By acting as a connected hub between patients, advocacy groups, physicians and BioPharma we aim to directly address some of the barriers that affect clinical trial recruitment and enrollment.  

We build trust and engagement with patients by offering one-to-one support at every level. As well as having a multi-lingual Patient Navigator team who operate globally, we work to break down language and informational barriers, by closely working with community patient advocacy groups. By working directly with all stakeholders in the recruitment funnel, we can reduce (geographical) barriers by effectively finding the most suitable options for patients, ultimately referring quality qualified and interested patients to trial smoothly. 

To find out more about how myTomorrows champions diversity, equity and inclusivity through our redefined and streamlined clinical trial recruitment process, click here.