Work

Attitudes About Clinical Trials of Medications in Older Hispanic/Latino Adults With Multimorbidity

Year: 2025

Type: article

Abstract: Hispanic/Latino individuals represent a rapidly growing segment of the US population, yet older Hispanic/Latino adults remain underrepresented in clinical trials of new medications [1, 2]. Since people of different ages, races, or ethnicities may respond differently to therapeutic agents [3-5], this gap raises concerns about medication efficacy and safety. This study explores barriers and facilitators of clinical trial participation among older Hispanic/Latino adults with multiple chronic conditions. We conducted focus groups between February and September 2023 with adults aged 65 years and older who self-identified as Hispanic/Latino of Mexican origin and reported taking five or more prescription medications. Participants were recruited from senior centers in Los Angeles and San Francisco through information sessions and flyers and from UCLA and UCSF through electronic health record data extractions and email invitations. Respondents were sampled based on their preferred language (English or Spanish) and previous participation in research studies (Supporting Information Figure S1). Focus groups were conducted in person or via Zoom, moderated by a Spanish-English bilingual researcher using a semi-structured guide to investigate participants' perspectives of clinical trial participation. Participants received compensation for their participation. Focus groups were analyzed in ATLAS.ti 23 using thematic analysis [6]. Theoretical saturation [7] was achieved. The UCSF Institutional Review Board (IRB) approved the study protocol. We conducted 14 focus groups with 93 participants (Table 1): nine with 61 participants without previous research experience and five with 32 participants with previous research experience, including 7 who had participated in clinical trials. The mean age was 72.1 years (SD = 5.4); 55 (59.1%) were female, and 51 (54.8%) opted for Spanish-speaking groups. See Supporting Information Tables S1 and S2 for additional participant characteristics. We identified major themes concerning clinical trial participation (Table 2). “We don't know. No one tells us.” [Female1/FG4/Translated from Spanish] “We need more information and to be included because it is not that we do not want to; it is that we are ignorant of many things.” [Female2/FG2/Translated] “A tea for everything. Tea for colic, tea for fever, tea for discomfort…that's what many of us Latinos are accustomed to.” [Male3/FG1/Translated] “Vicks VapoRub is legendary in the Latino community for being able to cure anything.” [Female2/FG14] “When you look at all these new drugs that are coming on TV and stuff, and you start listening to all their side effects and some of them say can cause death, can cause liver problems, kidney problems…I don't want to do that. I'm 70 years old. Why would I want to put myself at risk for something like that?” [Male4/FG8] “I have too many illnesses and I take too many pills…If it were going to help me to get rid of so much medicine they give you, I would accept, but if not, what is the point?” [Female4/FG2/Translated] “I would actually be interested in participating. My only obstacle might be if the location is too far from where I live because of transportation. My wife works some of the time, my children work, and there's just no time for it.” [Male1/FG6/Translated] “A lot of older Latinos, they're very loyal to their families and they have responsibilities taking care of either their own parents or like my sister she's taking care of her grandchildren… I think that's one of the reasons [Hispanic/Latino people do not participate in clinical trials].” [Male5/FG12] “I decided to participate in the clinical trial because my doctor was very clear on what the process involved. She went beyond explanation, and I was given information about it that I could read at home… It was very clear to me that it would help me, and it would help others as well. That was my decision.” [Female2/FG12] “[The doctor] was very trustworthy from the get-go. We went through biopsies and stuff. The way he was, how he took the time to explain, to make me feel like I did have a fighting chance to come out of this situation. He asked me if I wanted to be part of a clinical trial…I said, ‘If that's going help somebody, please do’… It's how the doctor approaches you and how he treats you.” [Male3/FG12] “If you have a really strong support system at home, that might help [with clinical trial participation]. I have two adult daughters, and they research with me and ask a lot of questions. They've been with me to the doctor and ask a lot of questions.” [Female1/FG13] “My daughter, she's the one who takes care of everything… I do handle some things, and I do speak English well myself, but for second opinions, she's the one who's in charge of second opinions because she has more schooling. I wasn't able to go to school, she did. So here, especially for important decisions, it's my daughter.” [Male2/FG6/Translated] “You need to do [recruitment] in layman terms for people because there's a lot of us out there, especially, I hate to say this, but Latino people, they're scared. If they don't understand something, and it's not in their language, they're not going to do it.” [Male2/FG7] “The language is important because if we don't even understand medical terminology in our own language, then much less in another. Or it gets poorly translated, and we understand whatever we think we understood. Think about it, in Central America they speak a little differently, and also a little differently in South America.” [Female3/FG3/Translated] “Someone who speaks their language. Someone who understands them, who knows some of the cultural patterns…You're not going to just go in there and convince them because it's a good [clinical trial]. It's not going to work.” [Female5/FG9] “Provide scholarships for our young people to become doctors so that when we come in the door, we see the individual and we say, ‘This person understands me. This person knows my soul. This person knows my culture and knows my fears, my anxieties, knows how to explain to me.’ Hasn't that happened to you all when you go into a doctor's office and the receptionist or the nurse is Latina or Latino? Right away, my blood pressure goes down.” [Female1/FG8] “The most effective approach, in my opinion, would be to organize more of these kinds of meetings [focus groups]. Those of us who've been part of such initiatives could be sent documents with this valuable information. You share the acquired knowledge within your circle, and gradually, more people get drawn to this cause… This continuous chain of information sharing, in my view, is how awareness would proliferate. Meetings like today's are a perfect avenue for such outreach.” [Male6/FG6/Translated] “The information is so important, whether it's on TV, on the radio, or anything else. We—at least personally, I'm not very good with the phone… More information that is tailored to older people, many of whom probably can't read or write. Many of the Latinos here are unfortunately in that situation. We need more information so that people can be informed and make decisions.” [Male2/FG5/Translated] Limited awareness was identified as a primary barrier. Many Spanish-speaking participants had never heard of clinical trials. Participants believed that Hispanic/Latino people do not oppose clinical trial participation but feel excluded from such opportunities due to language barriers, lack of health insurance, and technological challenges. Participants noted a strong reliance on traditional medicine and home remedies among the Hispanic/Latino community, contributing to an aversion to Western medicine. Some participants also mentioned a mindset of resignation in response to medical conditions as a cultural factor that may discourage clinical trial participation. Mistrust of health systems as a major barrier was portrayed as a collective conception that stems from past discrimination. Participants also noted that immigration status may potentially intensify mistrust since deportation remains a serious concern in the U.S. Many participants were concerned about drug safety, especially regarding age-related risks, side effects, and potential interactions with existing medications. Logistic challenges, such as transportation and scheduling conflicts, were also discussed. Participants who had previously joined research studies reported positive experiences and willingness to take part in future clinical trials. Two key motivators emerged: (1) rapport with physicians, as physician recommendation played a significant role in prior participation, and (2) family support, as many older Hispanic/Latino patients rely on adult children for healthcare navigation and decision-making. Participants suggested strategies to facilitate participation: (1) communicate in participants' preferred language, (2) employ study personnel who share their ethnicity and demonstrate cultural sensitivity, and (3) promote community-based outreach and mass media to engage older Hispanic/Latino adults. Our findings reveal key barriers to clinical trial participation among older Hispanic/Latino adults. While participants expressed general concerns about medication safety and logistical burdens, limited awareness and culturally specific barriers—especially mistrust—were particularly prominent. To build trust, involving physicians and family members in recruitment may be critical, as both were identified as influential in enrollment decisions. Our results align with existing recommendations of providing linguistically and culturally appropriate engagement to enhance clinical trial participation among ethnic minority groups [5, 9, 10]. However, participants also emphasized within-group diversity, including Spanish dialects, country of origin, and generational differences, which should be considered when developing interventions. This study has limitations. Participants were recruited from the West Coast, which may not reflect nationwide perspectives. The reported number of chronic conditions may not fully capture participants' health status since they were selected from a nonexhaustive list. Ten participants took fewer medications than the inclusion criteria, though their views were consistent with others. Understanding the preferences of older Hispanic/Latino adults is essential for improving clinical trial enrollment. This study identifies barriers specific to older Hispanic/Latino adults of Mexican origin. Additional research is needed to determine the generalizability of these findings across the broader Hispanic/Latino population and other minority communities. Study concept and design: Janice B. Schwartz and Derjung M. Tarn. Data collection, data analysis, and preparation of manuscript: Ruey-Ying Liu, Janice B. Schwartz, Bruno Renero-Hannan, Irene Del Mastro N., and Derjung M. Tarn. Dr. Schwartz and Dr. Tarn have previously been funded for unrelated research by investigator-initiated research awards from Bristol-Myers Squibb and Pfizer, as part of the American Thrombosis Investigator Initiated Research Program (ARISTA-USA). Supporting Information Figure S1. Focus group sampling Supporting Information Table S1. Focus groups with participants without research experience Supporting Information Table S2. Focus groups with participants with prior research experience Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Source: Journal of the American Geriatrics Society

DOI: 10.1111/jgs.19495

Authors: Ruey‐Ying Liu, Janice B. Schwartz, Bruno Renero‐Hannan, Irene Del Mastro N, Derjung M. Tarn

Institutions: National Chengchi University, University of California, San Francisco, University of California San Francisco Medical Center, SUNY Geneseo, University of California, Los Angeles

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDGs: Good health and well-being, Reduced inequalities

Open Access status: hybrid

Estimated APC paid: $4,760