Abstract
OBJECTIVE: To determine whether individuals in the United States who speak languages other than English (LOE) are excluded from federally funded pediatric clinical trials and whether such trials adhere to the National Institutes of Health policy regarding inclusion of members of minority groups. STUDY DESIGN: Using ClinicalTrials.gov, we identified all completed, federally funded, US-based trials inclusive of children ≤17 and focused on one of 4 common chronic childhood conditions (asthma, mental health, obesity, and dental caries) as of June 18, 2019. We reviewed ClinicalTrials.gov online content, as well as published manuscripts linked to ClinicalTrials.gov entries, to abstract information about language-related exclusion criteria. Trials were deemed to exclude LOE participants/caregivers if explicit statements regarding exclusion were identified in the study protocol or published manuscript. RESULTS: Of total, 189 trials met inclusion criteria. Two-thirds (67%) did not address multilingual enrollment. Of the 62 trials that did, 82% excluded LOE individuals. No trials addressed the enrollment of non-English, non-Spanish-speaking individuals. In 93 trials with nonmissing data on ethnicity, Latino individuals comprised 31% of participants in trials that included LOE individuals and 14% of participants in trials that excluded LOE individuals. CONCLUSIONS: Federally funded pediatric trials in the United States do not adequately address multilingual enrollment, a seeming violation of federal and contractual requirements for accommodation of language barriers by entities receiving federal funding.