Although providing language access in clinical drug trials is well-recognized as essential for producing objectively valid results through inclusion of various populations, most drug trials still do not encompass non-English speaking patients. As a result, the efficacy and reliability of such trials can be questionable.
A new study, “Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov,” published by Pediatric Research in 2025, tackles these issues. Pediatric Research publishes original research papers, reviews, and commentaries on the etiologies and treatment of diseases of children and disorders of development, extending from basic science to epidemiology and quality improvement.
Pediatric Research’s large study confirms the widespread exclusion of limited English proficient (LEP) people from clinical trials. Indeed, nearly 24% of the trials studied had specific English-speaking requirements. Such requirements and the resultant exclusion of people because of their national origin and LEP status represents differential treatment, indicating the prospect of illegal discrimination pursuant to Title VI of the 1964 Civil Rights Act and Section 1557 of the Affordable Care Act for trials funded or supported by the federal government.
The study analyzes language-based eligibility criteria across all 4,982 U.S. pediatric interventional clinical trials registered on ClinicalTrials.gov from 2019 to 2022.
The authors note that more than 20% of U.S. households have family members who speak a language other than English and are LEP. Indeed, they write further:
“The population of people aged five years and over in the United States (US) who speak a language other than English at home has tripled since 1980 to 21.7% of the total population, of which 61% speak Spanish. See, U.S. Census Bureau. American Community Survey Reports: Language Use in the United States.
See:
https://data.census.gov/table?q=DP02&y=2022 (2022)
Children in non-English speaking (NES) households are more likely to be socioeconomically disadvantaged, Hispanic, or Asian/Pacific Islander, and experience disparities in access and use of both preventive and specialty medical care. For over two decades, NES populations have also been excluded from clinical research, which may violate federal antidiscrimination regulations, compromise the generalizability of research results, and erode trust in the US research enterprise. While some studies have documented language-based disparities in pediatric clinical research, they are limited in scope and not representative of all US pediatric trials.”
Not surprisingly, the number of clinical trials requiring English proficiency decreased while those providing language access services increased during the time period analyzed, 2019-2022. These results coincide with the COVID pandemic, “at a time of increased sensitivity to the inclusion of diverse populations in research. This trend, therefore, may not portend incremental progress in accommodating language preferences; careful monitoring is necessary to determine whether diverse language services continue to increase, stabilize, or regress over time.”
The authors concluded that:
“Our study evaluating language requirements in a large, national sample of pediatric clinical trials underscores the persistent exclusion of LEP participants. Focused efforts to report language-based eligibility criteria and eliminate unjustified exclusion can advance more generalizable and equitable clinical research for the growing US pediatric NES (non-English speaking) population…
Of 4,982 U.S. pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 70.0% did not include any information about language while 23.4% explicitly included English language requirements.
Of the trials requiring English, only 14.4% provided a justification for the requirement. Trials with a posted protocol were more likely to require English than all registered trials. Trials with industry sponsors, drug-based/biological interventions, or a treatment focus were less likely to mention language information than all registered trials.”
The justifications for participants in the trials to speak and read English are well-known excuses for not providing language access. Many such ostensible justifications are legally questionable. They include, according to the study:
“Meeting translation costs is not possible in this study; Cost; Non-English-speaking parents will be excluded due to time constraints to perform the consent process; Children who speak only Spanish are not eligible because the Rome questionnaire [used in clinical trials included in the study] and psychological testing [used in clinical trials included in the study] are not available in Spanish; Assessment tools not validated; Non-English-speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker; [Un]availability of trained staff; Other [non-English] languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable preterm population; Additionally…the time to consent is a narrow window; Time sensitivity; Because of the emphasis on English phonological patterns, all participants will be monolingual English learners or report dominant exposure to English from infancy (i.e., must have begun learning English by age 2, per parent report).”
The authors did not endorse the “justifications” for not offering language services and for not including LEP people, recognizing the potential for ethically challenged trials and legally cognizable discrimination:
“However, language requirements raise ethical concerns when justified by a lack of assessment tools in languages other than English, convenience, or cost. Justification based on the lack of availability of multilingual clinical staff raises important questions of potential discrimination in clinical research. Translation and interpreter services are accommodations that are readily available, even if they require additional resource commitment.”
Some of the trials analyzed did provide language access. The authors report that such access was offered in American Sign Language, Arabic, Armenian, Dari, Dutch, French, German, Haitian Creole, Italian, Luganda, Mandarin, Pashto, Portuguese, Russian, Swahili, Turkish, and Vietnamese. The study also addressed that when English is not the participant’s primary language, “a staff interpreter, translator, or licensed telephone interpreter will explain the full consent form.
“If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. If the recruitment accrues beyond 4–6 non-English speaking participants, the consent forms will be translated into this language for future participants.”
To ensure that future trials do not preclude LEP people from participation, the study’s authors advocate for greater oversight and awareness of language access necessities. They write:
“To advance inclusion, we recommend that Institutional Review Boards critically evaluate proposals for efforts to identify, recruit, and retain NES populations—including requiring the explicit provision of language services such as translation and interpreter availability—as part of their scientific and ethical review. These changes will support non-discrimination and conformance with federal law and may also result in more representative research that will benefit a larger, more diverse population.”
© Bruce L. Adelson 2025 All Rights Reserved The material herein is educational and informational only. No legal advice is intended or conveyed.
Bruce L. Adelson, Esq., is nationally recognized for his compliance expertise. Mr. Adelson is a former U.S Department of Justice Civil Rights Division Senior Trial Attorney. Mr. Adelson is a faculty member at the Georgetown University School of Medicine and University of Pittsburgh School of Law where he teaches organizational culture, implicit bias, cultural and civil rights awareness.
Mr. Adelson’s blogs are a Bromberg exclusive.