ArticleClinical trials (London, England)2015
Characteristics of clinical trials that require participants to be fluent in English.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed.
- Minority Enrollment in Phase II and III Clinical Trials in Urologic Oncology.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Article
- Researcher Perceptions of Inclusion of Study Participants Who Use Languages Other Than English.JAMA network open · 2025Article
- Voices unheard: Bridging language gaps, ensuring equity and inclusion of non-native speakers in health research and clinical trials.Nursing open · 2024Article
- Analysis of eligibility criteria in Alzheimer's and related dementias clinical trials.Scientific reports · 2024Article
- Racial and ethnic disparities in psychological care for individuals with FASD: a dis/ability studies and critical race theory perspective toward improving prevention, assessment/diagnosis, and intervention.Frontiers in public health · 2024Article
- Exclusion of Families Who Speak Languages Other than English from Federally Funded Pediatric Trials.The Journal of pediatrics · 2023Review
- Healthcare experiences of patients with Down syndrome from primarily Spanish-speaking households.American journal of medical genetics. Part A · 2023Article
- Traversing the Aging Research and Health Equity Divide: Toward Intersectional Frameworks of Research Justice and Participation.The Gerontologist · 2022Article
- How Should Representation of Subjects With LEP Become More Equitable in Clinical Trials?AMA journal of ethics · 2022Article
- Health Equity Tourism: Ravaging the Justice Landscape.Journal of medical systems · 2022Review
- Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov.PLoS medicine · 2021Article
- Article
- Knowledge translation and better health and health care for migrants in Canada: What is the responsibility of health funders and researchers?Canadian family physician Medecin de famille canadien · 2021Article
- Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic.Journal of health communication · 2020Article
- Cancer Health Literacy and Willingness to Participate in Cancer Research and Donate Bio-Specimens.International journal of environmental research and public health · 2018Article
- Temporal trends and characteristics of clinical trials for which only one racial or ethnic group is eligible.Contemporary clinical trials communications · 2018Article
- Racial Differences Among Factors Associated with Participation in Clinical Research Trials.Journal of racial and ethnic health disparities · 2016Article
- Electronic Health Record-Based Algorithms May Improve Identification of Cases of Atypical Diabetes, Including in Groups Underrepresented in Biomedical Research.Diabetes, obesity, and cardiometabolic CAREArticle
- Engaging Sub-Saharan African Migrants in Social and Health Studies in Australia: Research and Ethical Challenges.Ethics & human researchArticle
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
BACKGROUND/
aimsDiverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial.
methodsWe randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses.
resultsEnglish fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p < 0.001 from Chi-squared test). Industry-sponsored trials had low rates of English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP codes with larger Hispanic populations were less likely to have English fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, p<0.001 for restricted cubic spline term) or Asian (odds ratio=1.16 for linear term, 95% confidence interval=1.07-1.25, p<0.001) were more likely to have English fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase, 95% confidence interval=1.001-1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others.
conclusionThe proportion of clinical trials registered with ClinicalTrials.gov that have English fluency requirements for study inclusion has been increasing over time. English-language restrictions are associated with a number of characteristics, including the demographic characteristics of communities in which the sponsoring institutions are located.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.