Over the years, migration trends have changed, and the United States still has the highest rates of immigrants globally. This reality has impacted public health and healthcare access, demanding legislation and policies such as providing prenatal care to women regarding their immigrant status, which has been adopted in 18 states (1). On the other hand, the United States has the highest number of active clinical trials globally, with over 40,000, raising questions about representation, inclusion, and actual safety and efficacy of medicines and vaccines in the population.
These facts are critical regarding the country’s clinical research planning and protocol design. For example, the new law enforcement FDORA, approved recently, requires sponsors to consider underrepresented populations and submit diversity action plans to the FDA, emphasizing diversity in a broader meaning. Including the Hispanic population on enrollment targets is critical in terms of representation, as 62+ million Hispanics live in the United States, representing approx 19% of the total population, that is to say, the second largest ethnic group (2).
How to Engage with the Hispanic and Hispanic American Population
It is crucial for sponsors, sites, and CROs to not only translate the clinical trial material to Spanish but to culturally appropriate the language in documents such as the eConsent, as 71% of Hispanics speak another language besides English, and 28% state that they are not fluent in English (2). Enrollment also requires tools such as bilingual documentation, campaigns, and channels to engage more with the community. Additionally, having bilingual staff can help address education and communication needs related to clinical trial participation, privacy, benefits, and importance.
Considering cultural differences can also help increase the enrollment of Hispanic people. Despite the multiple backgrounds, there are cultural similarities, such as large, tight families with strong family values (3) with prominent father, mother, and grandparent roles, which is essential to acknowledge in the recruiting stage by planning the engagement and involvement of family members in the discussions and conversations about implications of participating in a clinical trial.
Identifying other cultural behaviors, interests, community life, customs, celebrations, and traditions are insights about participants’ needs that should be considered when scheduling visits or doing site follow-up activities. Hispanics tend to be group-oriented; thus, a community and referral approach is recommended in the enrollment stage.
Technology is also helping reduce barriers
Such as language, transportation, work schedules, and child care through DCT and hybrid protocol designs to collect participant data remotely (ePROs and eCOAs). Digital Marketing and Recruitment systems help engage the Hispanic communities better, track interactions, register family relationships, consider concerns from the mother, who may have the final word when deciding to participate, and interact through different channels, including WhatsApp, the preferred communication channel by Hispanics.
Technology can also help manage smart scheduling and understand when they are available after work to send reminders and alerts to help with retention and patient follow-up. Systems that record all patient history in clinical research and boost real-life stories within the community in Digital Channels will increase future participants’ interest and trust. Customer success and support need to consider physicians and researchers within the Hispanic population, and technology has to embed language preferences and cultural expressions per user needs. Other strategies, such as smartphone provisioning, pre-setup, and data recharge, can be helpful for participant engagement, interaction, and retention (check this amazing all-in-one system, Trial360, that does it all).
Investigators have to consider building long-term relationships and engagement with the Hispanic population; using digital technologies can be a helpful resource to reduce access and retention barriers and increase recruitment, education, and communication channels to involve and give Hispanic participants an active role in clinical research.
References:
- KFF, 2023. Key Facts on Health Coverage and Care of Immigrants. Link: https://www.kff.org/racial-equity-and-health-policy/fact-sheet/health-coverage-and-care
- OMH U.S. Department of Health Service Office of Minority Health, 2020. Profile Hispanic/Latino Americans. Link: https://minorityhealth.hhs.gov.
- InterExhange, 2020. Latino and Hispanic Culture in the U.S. Link: https://www.interexchange.org
