Health disparities are evident across a number of factors, but are especially apparent along lines of race and ethnicity. 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 would we know that a particular therapy will work equally well in all groups if such groups aren’t part of clinical trials? Can access to promising new treatments from a study (along with the careful medical attention from the research team) help improve outcomes for study participants? Developing a culturally intelligent approach is required to engage clinical trial participants from diverse backgrounds to achieve this.
FDA’s increased push 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. This can include, but is not limited to:
- 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
A Race and Ethnicity Diversity Plan for the FDA requires an understanding of a number of factors.
Language as a barrier to clinical trial accrual
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.
Participating in Clinical Trials
Immigrants tend to be underrepresented in clinical trials, particularly people from non-English speaking countries. This is due to a few factors, including language barriers, work obligations, and conflicting cultural practices in medicine. Being Limited English Proficient (LEP) is the most 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, there may also be an income barrier. Some ethnic groups tend to be less financially secure, making it more challenging to participate in clinical trials. Compared to Caucasians, many ethnic groups are more likely to work inflexible hours or have family obligations. Overall, immigrants are more likely to have reservations about signing up for a trial; these attitudes could be remedied if clinical trial organizers changed the way trials are conducted. For one thing, transport and trial location need to become more convenient for immigrant communities.
Many diseases are heavily influenced by genetic predispositions and environmental factors, where some ethnic groups are more at risk than others. “We’re not all the same physiologically,” says Clyde Yancy, MD, a diversity expert at Northwestern University Feinberg School of Medicine. “Whether it’s because of age, illness, or genetic ancestry, we likely all metabolize drugs differently; we may respond to devices differently.” Trial testing lacking diversity will demonstrate distorted results and not reflect our population accurately.
Why Diversity in Clinical Trials is Critical
Diversity in recruiting will improve the 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. This gap results in the clinicians having limited trial research inhibiting treatment options for this group.
According to FDA Commissioner Robert M. Califf, MD: “The U.S. population has become increasingly diverse, and ensuring that meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health. Achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.” The FDA has drafted a set of guidelines to foster this new approach.
Solutions for Increasing Diversity
Healthcare organizations can change how clinical trials are managed. One option would be to eliminate transportation barriers. 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 why certain groups are underrepresented, many minorities answered, “I was never approached.”
Another solution would be to create translated resources for ethnic minorities to comprehend. 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.
Additionally, clinical research teams could benefit from developing a more culturally inclusive workforce. This includes having teams reflect the communities you are trying to reach. This would also include diversity training to instill culturally sensitive protocols when interacting with diverse patients.
What is Cultural Intelligence?
Cultural intelligence refers to fostering cross-cultural communication. This goes beyond translation, interpretation, transcreation and more. Culture shapes psychological processes, human experiences and ultimately affects context. Cultural adaptation doesn’t simply address the obvious differences, but it is about shifting communication to address the less obvious differences.
Interpreting Cultural Values
Cultural intelligence often involves the recognition of common behaviors. 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.
Depending on the culture, you could be perceived as either rude or straightforward based on your level of assertiveness. Being culturally intelligent means knowing what tone to take in a conversation and how to phrase specific questions or comments.
It is also critical to be familiar with varied cultural customs, political structures, and legal systems. This is done to assure the patient that the provider’s methods are safe and legal. If the patient’s country enforces a different set of medical laws, the healthcare provider may need to explain how the United States differs in its laws.
Aside from providing essential language services, a culturally intelligent approach 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
Awareness and acknowledging such factors work to enhance your relationship with study participants.
CQ fluency’s experience
At CQ fluency, we’ve developed a proprietary process for delivering culturally intelligent solutions. To start with, we thoroughly review content for any cultural “red-flags” and supply recommendations to address such.
CQ fluency specializes in providing communication solutions for healthcare and life science organizations. We have aligned our human capital, technologies, and processes to ensure overall quality and have earned the trust of organizations such as Merck, Pfizer, Novartis and more. What makes CQ fluency different is that we focus on life sciences to have a deep understanding of your industry but still take the time to understand your specific challenges. Our nimble, collaborative culture allows us to apply experiences from across our customers to ensure we properly address your needs. The result is an in-depth translation and culturally intelligent communication solutions for researchers, clinicians, and healthcare providers in clinical trial settings. Our approach ultimately creates better healthcare outcomes for everybody involved.