By Farhanna Sayegh, executive director, multicultural marketing, CQ fluency
While the two-year pandemic hotly spotlighted health disparities in the United States, decades-long systemic inequities in how people from diverse communities understand, access, and use healthcare are directly linked to racism and discrimination. That’s why stakeholders spanning all areas of healthcare have a responsibility and an opportunity to close gaps in care so that we can take a culturally intelligent approach to disease management in the future.
One way to address disparities is by increasing diverse participation in clinical trials. Roughly 18% of Americans are Hispanic or Latino, but they make up only 1% of clinical trial participants. Less than 3% of US-based clinical trial participants are Asian, despite making up ~6% of the U.S. population. How do we know that a particular therapy will work equally well in all groups if such groups aren’t part of clinical trials?
Diversity in recruiting will improve health outcomes for a broader range of people. For example, African American patients tend to respond differently to specific pharmacotherapies. ACE inhibitor drugs can be less effective in treating African American patients than Caucasian patients. African-American patients, making up 13% of the population, only account for 5% of clinical trial participants.
FDA Calls for Diversity in Clinical Trials
In April 2022, the U.S. FDA advised drug companies to submit plans for how they will increase the number of underrepresented groups in clinical trials, including:
- Plan and develop cultural interventions (sustainable and scalable) to address medical mistrust and negative attitudes
- Establish meaningful community partnerships to foster trust
- Adapt protocol designs to drive diversity
- Implement staff training programs to adequately address culture and bias
- Create a post-market plan if your trial still needs to address how to drive adequate representation of Black, Hispanic, Native American, Asian, or other persons of color
However, these steps cannot happen without considering how interventions, educational programs, and marketing plans are communicated to diverse populations with respect to their cultural norms and where English is not the primary language.
Cultural intelligence refers to fostering cross-cultural communication, which can involve the recognition of common behaviors. Beyond the visual cues (dress, festivals, foods, and language) that define a patient population, there are “hidden” attributes (beliefs, manners, biases, beauty ideals, et.al.) that build rich and diverse heritages. For example, Asian cultures are known more for collectivism, while Western countries tend to emphasize individualism. Therefore, in Asian cultures, oftentimes family is involved in the decision making for healthcare.
Language Barriers Impede Clinical Trial Enrollment
According to the U.S. Census Bureau, more than 21 percent of United States residents ages 5 and up (>66M) speak a language other than English as their primary language at home. Of these, 39 percent (>25M) have Limited English Proficiency (LEP), meaning they speak English less than well. Navigating the U.S. healthcare system to access medications and health services is complicated from multiple perspectives:
- For patients: Decoding complicated communications that use medical jargon and legal language can be challenging. Also, uninsured and low-income individuals may not explore participating in clinical research due to assumptions of cost.
- For providers: Medical practices are burdened by records management and focused on quality care and therefore have limited time to conduct research on clinical trials, resulting in lack of information about the studies that are relevant to their patients. Additionally, although professional language interpretation improves the quality of care for LEP patients, it remains underused. A report from the Center for Information and Study on Clinical Research Participation (CISCRP) found that 71% of people worldwide who have not participated in a clinical trial would be willing to. Yet only 25% of people managing a disease have had their doctor or nurse recommend a clinical trial as a treatment option.
Immigrants tend to be underrepresented in clinical trials, particularly people from non-English speaking countries, often because of language barriers, work obligations, and conflicting cultural perspectives and practices in medicine. Being Limited English Proficient (LEP) is a significant barrier preventing people from participating in clinical trials. Being in a trial environment can be an overwhelming experience for a non-native with limited English-speaking abilities and a lack of comprehension.
Aside from language and cultural differences, some ethnic groups tend to be less financially secure and are more likely to work inflexible hours or have family obligations, creating barriers to clinical trial participation. Further, immigrants are more likely to have reservations about signing up for a trial, though these attitudes might improve if clinical trial organizers made it easier to participate. For example, transport and trial location need to become more convenient and accessible.
Solutions for Increasing Diversity
Thinking through translation, logistics, and culturally intelligent approaches to clinical trial recruitment at the start will improve diversity and reduce the risk for results distorted by patient homogeneity.
Healthcare organizations can change how clinical trials are managed. Rutgers University researchers found that decentralized clinical trials increased the diversity of patients. People in immigrant communities are more likely to participate in trials provided by local physicians conducted near their neighborhood. In addition to an environmental change, redesigning a trial’s eligibility standards would further support diversity. Some patient criteria are based on body mass index or white blood cell count, which could eliminate many ethnic groups. Organizers could also focus on creating a more inviting approach. When asked in a report by the Association of American Colleges why certain groups are underrepresented, many minorities answered, “I was never approached.”
Another solution is to create culturally sensitive, translated resources for ethnic minorities. The more informed a person is about an upcoming trial, the more confident they feel about enrolling. Study teams that are successful with driving diversity demonstrate cultural intelligence by translating/localizing patient brochures and providing an interpreter for the clinical trial.
A culturally intelligent approach to translation when recruiting LEP people to participate in research should address:
- average reading level
- gender implications, pronouns, and proper noun
- puns and idiom
- images, colors, motifs, or symbols
- medical beliefs, religious practices, and political beliefs
- perspectives on community and family dynamics
- terms that don’t exist in the target language
- tone, affection, formality, and humor
- perspectives on health and death
- beliefs about medication use
- in-language URLs
Additionally, clinical research teams benefit from developing a more culturally inclusive workforce, with staff that reflect the communities you are trying to reach. This should also include diversity training to instill culturally sensitive protocols when interacting with diverse patients.
Research drives our understanding of complex health conditions. Health providers, researchers, and contract research organizations (CROs), and the companies and organizations investing in research can contribute to improving health outcomes by committing to incorporating cultural intelligence and translation into their clinical trial recruitment planning from the start. As we learn more about diverse patient populations’ response to treatment approaches and disease management through research, we can develop actionable approaches that healthcare providers and patients can think through, together, to make patient-centered decisions about their personal health and disease management aligned to their preferences.