Challenges and Solutions for the Latinx Population to Effectively Participate in Clinical Trials

Guidelines by the National Institutes of Health in 1994 mandated the inclusion of minority participants in clinical research. Despite these efforts, there is still inadequate representation of Latinx groups in U.S. clinical trials, which results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results. 

Insightful solutions to fill the gap are suggested in this article

By Karen Mancera Cuevas MS, MPH, CHES

Associate Director, Research Projects at Northwestern University, Feinberg School of Medicine, Chicago USA

Challenges and Solutions for the Latinx Population to Effectively Participate in Clinical Trials


In the past decades, as the first-generation Latinx population has become more acclimated to the U.S. medical system, there has been ongoing interest in how to effectively engage the multi-faceted population comprised of a variety of nationalities, cultures, traditions, and dialects into clinical trials. Inclusion in clinical trials is important as Latinx are largely underrepresented in ongoing recruitment and retention efforts 1 in both academic and pharmaceutical studies. Guidelines published by the National Institutes of Health in 1994 mandated the inclusion of minority participants in clinical research 2. Despite these efforts, there is still inadequate representation of racial/ethnic groups in clinical trials, which results in inequitable distribution of the risks and benefits of research participation and reduces the generalizability of trial results 3. This is because the purpose of clinical trial research is to examine new ways to treat, prevent, and diagnose diseases or conditions 4.

Providers in many traditional clinical settings have limited time, resources, or personnel to effectively engage interested Latinx patients into studies 5. Although these factors exist, the role of trust with providers is critical for Latinx patients to participate in clinical trial research 6 that must be leveraged with added organizational infrastructure to facilitate participation. Patients who are less educated may not feel comfortable or even feel empowered to advocate for their interest in clinical research 7, understand the topic 8, or may even express fear of participation9.  Latinx participants need to find meaning in the relationship and proper accommodations such as scheduling mutually convenient times around work schedules and providing meaningful incentives are critical 10 in addressing cultural salient participant behavior. Increasing Latinx providers and advocates 1 are also integral to recruitment efforts and include having providers devote more time with study patients which may ultimately impact feelings of altruism as a motivator for participation 1.  Moreover, integration of clinical research within the clinic, as part of a patients overall health care plan, is usually absent or a final alternative therapy.  Earlier consideration of applicable clinical trials could provide the under resourced Latinx community with access to diagnostic procedures and therapies, which are usually cost prohibitive.

Solutions include addressing low literacy efforts and developing educational materials that effectively engage the intended Latinx audiences in the language of origin. As voiced in a study of Latino clinical trial participants, “If the message is going to be translated from English to Spanish, you have to be sure to choose the right words.” 1 Examples include language-congruent care, that influences behaviors, attitudes, and policies in clinical trial recruitment and is a key element in dissemination of awareness with Latinx patients 11. The educational method most applicable are audiovisual materials that offer advantages to Latinx populations in that they have been shown to have high rates of acceptability 12 over group or individual education sessions 13. Additionally, clinical trial studies indicate that health education materials, particularly those with a focus on promoting behavior change, are more successful when “transcreated” and available to the target population in their native language 14 where the text is not merely translated into another language; but it is reconstructed to meet the health literacy and informational needs of the target audience in a manner that is culturally appropriate 15.

Patient-centered trial designs16 incorporating Latinx centered solutions to address participant burden are necessary to promote increased trial participation. Measures include reduction of extra procedures, explanation of cost, and education to resolve negative perceptions of clinical trials and medical expertise5. Assurance from clinical trial recruitment staff should include the message that immigration status will not be documented1. The role of patient navigators has also been welcomed by Latinx participants as a way to overcome barriers although, findings have yielded greater application through clinical trial retention measures rather than recruitment efforts although navigated participants have demonstrated higher overall retention rates 17. Additionally, partnership with selected faith-based community-based organizations may increase participation rates with selected Latinx population groups (i.e. older adults) 8. Although recommendations are provided, health disparities outcomes among Latinx clinical trial patients will continue as long as therapies are not tested equally in targeted communities. This inequity needs to be properly addressed for future measures to be adapted in Latinx communities that will benefit from participation.



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