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

Pediatric Research volume 98, pages 839–843 (2025)Cite this article

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.

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Data availability

The computer program and full data are available upon request.

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Acknowledgements

We thank Ava Glazier (AG) and Molly Siegal (MS) for classifying language requirements and services as well as contributing to discussions about clarifying discrepancies.

Funding

Funding was provided by Harvard Catalyst (NCATS, NIH UL1TR002541) to support statistical consultation. The content is solely the responsibility of the authors.

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Authors and Affiliations

  1. Harvard College, Cambridge, MA, USA

    Akila V. Muthukumar & Kavya M. Shah

  2. Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, Boston, MA, USA

    Akila V. Muthukumar & Barbara E. Bierer

  3. Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA

    Robert J. Glynn

  4. Department of Medicine, Harvard Medical School, Boston, MA, USA

    Robert J. Glynn & Barbara E. Bierer

  5. Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA

    Barbara E. Bierer

Authors
  1. Akila V. Muthukumar
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  2. Kavya M. Shah
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  3. Robert J. Glynn
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  4. Barbara E. Bierer
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Contributions

Each author has met the Pediatric Research authorship requirements. A.V.M., B.E.B. conceived of the project and study design. A.V.M. performed the initial analysis and had unrestricted access to all data and prepared the first draft of the manuscript. R.J.G. performed the statistical analysis. K.M.S., and R.J.G., B.E.B. reviewed the data and analysis, and reviewed and edited the manuscript. All authors read and approved the final manuscript and take full responsibility for its content, including the accuracy of the data.

Corresponding author

Correspondence to Barbara E. Bierer.

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The authors declare no competing interests.

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Muthukumar, A.V., Shah, K.M., Glynn, R.J. et al. Persistent exclusion of non-English speakers in Pediatric research: a national analysis using ClinicalTrials.gov. Pediatr Res 98, 839–843 (2025). https://doi.org/10.1038/s41390-025-03845-0

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