Abstract Over one-fifth of US households speak a language other than English. 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. Because language-based exclusion, if extensive, would limit the generalizability of the results of the research, we performed a systematic analysis of language-based eligibility criteria across all 4982 US pediatric interventional clinical trials registered on ClinicalTrials.gov from 2019 to 2022. We found that 70.0% [95% CI: 68.8–71.3%] of trials did not include any information about language while 23.4% [22.2–24.5%] had explicit English language requirements, of which only a minority (14.4%) included justifications for the limitation. Conversely, 6.6% [5.9–7.3%] of trials accommodated non-English languages. Trials with a posted protocol were more likely than all registered trials to include English language requirements (P < 0.00001). Trials with a federal sponsor, a behavioral intervention, or a focus on prevention or supportive care were more likely to report information about language when compared to all registered trials (P < 0.001), while trials with industry sponsors, drug or biological interventions, or a focus on treatment were less likely to do so (P < 0.001). Although modest, the percentage of trials requiring English decreased and the percentage offering language services increased from 2019 to 2022. Impact Statement <UnorderedList Mark="Bullet"> <ItemContent> Of 4982 US 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. </ItemContent> <ItemContent> Trials with a posted protocol were more likely to require English than all registered trials. </ItemContent> <ItemContent> Trials with industry sponsors, drug-based/biological interventions, or a treatment focus were less likely to mention language information than all registered trials. </ItemContent> </UnorderedList>

Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov

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发表日期：

2025年1月22日

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Akila V. Muthukumar,
Kavya M. Shah,
Robert J. Glynn,
Barbara E. Bierer

摘要

Abstract

Over one-fifth of US households speak a language other than English. 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. Because language-based exclusion, if extensive, would limit the generalizability of the results of the research, we performed a systematic analysis of language-based eligibility criteria across all 4982 US pediatric interventional clinical trials registered on ClinicalTrials.gov from 2019 to 2022. We found that 70.0% [95% CI: 68.8–71.3%] of trials did not include any information about language while 23.4% [22.2–24.5%] had explicit English language requirements, of which only a minority (14.4%) included justifications for the limitation. Conversely, 6.6% [5.9–7.3%] of trials accommodated non-English languages. Trials with a posted protocol were more likely than all registered trials to include English language requirements (P < 0.00001). Trials with a federal sponsor, a behavioral intervention, or a focus on prevention or supportive care were more likely to report information about language when compared to all registered trials (P < 0.001), while trials with industry sponsors, drug or biological interventions, or a focus on treatment were less likely to do so (P < 0.001). Although modest, the percentage of trials requiring English decreased and the percentage offering language services increased from 2019 to 2022.

Impact Statement

Of 4982 US 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.