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

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.