How Should Representation of Subjects With LEP Become More Equitable in Clinical Trials?

Alhalel, Jonathan; Francone, Nicolás; Post, Sharon; O’Brian, Catherine A.; Simon, Melissa A.

doi:10.1001/amajethics.2022.319

Cited by 13 publications

(9 citation statements)

References 23 publications

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“…Additionally, COVID-19 treatment trials were typically conducted among inpatient populations, which were likely disproportionately Hispanic or Latino owing to the relative lack of primary care services on contracting COVID-19 and the increased risk of COVID-19–associated hospitalization among Hispanic or Latino groups . The present findings about Hispanic or Latino representation stand in contrast to prior studies for COVID-19 and other diseases, which have found low enrollment of Hispanic or Latino populations in trials owing to institutional and/or systemic racism, distrust of the health care system, lack of access to clinical trial centers, low socioeconomic status, and language and communication barriers . The underrepresentation of Hispanic or Latino participants indicated in some previous studies may also be related to poor reporting of Hispanic or Latino identity when using administrative records .…”

Section: Discussioncontrasting

confidence: 90%

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

et al. 2023

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ImportanceSince the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials.ObjectiveTo investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.Data SourcesIdentified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022.Study SelectionIncluded studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included.Data Extraction and SynthesisData on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19.Main Outcomes and MeasuresSex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19.ResultsOverall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P &lt; .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P &lt; .001).Conclusions and RelevanceIn this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found. Strategies to better ensure diverse representation in COVID-19 studies are needed, especially for prevention trials.

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Section: Discussioncontrasting

confidence: 90%

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

et al. 2023

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“…28 Given federal guidance on inclusion of non-English-speaking participants in clinical trials is even sparser, 14 it has become clear that measures are not routinely being taken to include participants with limited English proficiency in clinical trials. 9 By including individuals who speak different languages in clinical research, we include individuals of different identities and ancestries. Yet, language presents a unique consideration among other identities.…”

Section: Call For Systemic Changementioning

confidence: 99%

“…Although we are committed to understanding the many barriers that make the enrollment of a diverse population a challenge, we focus in this article specifically on language. There has been a call to increase inclusion of individuals with limited English proficiency in all phase 3 clinical trials, 9 yet this remains an elusive goal even for Parkinson's trials specifically focused on fostering inclusion of underrepresented populations in Parkinson's research. 8 Speaking a language other than that in which the trial has been designed raises several complex and unique challenges that may not be fully appreciated by scientists in study design.…”

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confidence: 99%

Inclusion of Non–English‐Speaking Participants in Studies of Parkinson's Disease: A Call to Action

et al. 2022

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“…The alacrity with which white (non-Hispanic and Hispanic), English-speaking caregivers responded to the study-compared to the near nonexistent representation from the Spanish-speaking community-reflects a disparity in clinical research participation noted across communities with limited English proficiency (Alhalel et al, 2022;Cavazzoni et al, 2020;Egleston et al, 2015) and more generally, the deeper limitations of suggested approaches to outreach to and share information with these diverse communities (NYU Langone Health Office of Science and Research, Clinical and Translational Science Institute, 2022) that are further affected by rare conditions.…”

Section: Introductionmentioning

confidence: 99%

Healthcare experiences of patients with Down syndrome from primarily Spanish‐speaking households

Chung

Krell

Pless

et al. 2023

American J of Med Genetics Pt A

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We report on the health care experiences of individuals with Down syndrome (DS) from families who are primarily Spanish-speaking. Data were collected through three methods: (1) a nationally distributed, 20-item survey, (2) two focus groups with seven family caregivers of individuals with DS who self-identified as living in primarily Spanish speaking households, and (3) 20 interviews with primary care providers (PCPs) who care for patients who are underrepresented minorities. Standard summary statistics were used to analyze the quantitative survey results. Focus group and interview transcripts, as well as an open-ended response question in the survey, were analyzed using qualitative coding methods to identify key themes. Both caregivers and PCPs described how language barriers make giving and receiving quality care difficult. Caregivers additionally described condescending, discriminatory treatment within the medical system and shared feelings of caregiver stress and social isolation.Challenges to care experienced by families of individuals with DS are compounded for Spanish-speaking families, where the ability to build trust with providers and in the health care system may be compromised by cultural and language differences, systemic issues (lack of time or inability to craft more nuanced schedules so that patients with higher needs are offered more time), mistrust, and sometimes, overt racism. Building this trust is critical to improve access to information, care options, and research opportunities, especially for this community that depends on their clinicians and nonprofit groups as trusted messengers. More study is needed to understand how to better reach out to these communities through primary care clinician networks and nonprofit organizations.

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How Should Representation of Subjects With LEP Become More Equitable in Clinical Trials?

Cited by 13 publications

References 23 publications

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

Inclusion of Non–English‐Speaking Participants in Studies of Parkinson's Disease: A Call to Action

Healthcare experiences of patients with Down syndrome from primarily Spanish‐speaking households

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