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Background <p>Language requirements for enrollment in randomized controlled trials (RCTs) are rarely stated; however, due to intersectionality of language, race, and ethnicity, assessing language stipulations in trials on diseases disproportionally affect racially and ethnically diverse individuals is needed. We investigated language requirement frequency, eligibility criteria readability, and race and ethnicity reporting from RCTs in high-impact publications and public database ClinicalTrials.gov.</p> Methods <p>This cohort study included 35 RCTs and 42723 participants from systematic searches in MEDLINE, Scopus, EBSCO, Web of Science Core Collection, World Health Organization COVID-19 database April 2017-December 2025. We included drug RCTs on heart disease, stroke, cancer, respiratory disease, diabetes, and COVID-19, on ClinicalTrials.gov and published with ≥75% US participants. We assessed language requirements frequency in eligibility criteria in publications, protocols, informed consent forms, and ClinicalTrials.gov, and readability of consent forms and eligibility criteria in protocols and ClinicalTrials.gov according to funder and disease.</p> Results <p>We report 58% of industry-funded RCTs lack mention of languages in eligibility criteria or trial documentation. The median (IQR) readability of eligibility criteria assessed with Flesch-Kincaid Grade (FKG), Gunning Fog (GF), and Simplified Measure of Gobbledygook (SMOG) is higher than the recommended eighth-grade level in protocols with FKG = 12.7 (11.0-13.9), GF = 14.5 (12.4-15.4), and SMOG = 13.7 (12.1–14.4) and ClinicalTrials.gov with FKG = 12.9 (10.8-13.9), GF = 14.0 (12.2–15.3), and SMOG = 13.9 (12.2–15.6). Informed consent forms also have reading grade levels higher than recommended for the general public, with FKG = 8.2 (7.3–9.3), GF = 9.3 (8.8-10.8), and SMOG = 10.8 (10.2-11.8).</p> Conclusions <p>Involving stakeholders during RCT design is needed to encourage explicit language reporting and high readability, which could be instrumental in RCT accessibility and equity.</p>

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Systematic analysis of English requirements in US-based clinical trials for diseases disproportionately distributed among ethnicities

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月24日

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  • Shelly Melissa Pranić,
  • Ksenija Baždarić,
  • Maria Dulce Estêvão,
  • Iván Pérez-Neri,
  • Vinayak Mishra,
  • Joanne A. McGriff,
  • Anika Pulumati

摘要

Background

Language requirements for enrollment in randomized controlled trials (RCTs) are rarely stated; however, due to intersectionality of language, race, and ethnicity, assessing language stipulations in trials on diseases disproportionally affect racially and ethnically diverse individuals is needed. We investigated language requirement frequency, eligibility criteria readability, and race and ethnicity reporting from RCTs in high-impact publications and public database ClinicalTrials.gov.

Methods

This cohort study included 35 RCTs and 42723 participants from systematic searches in MEDLINE, Scopus, EBSCO, Web of Science Core Collection, World Health Organization COVID-19 database April 2017-December 2025. We included drug RCTs on heart disease, stroke, cancer, respiratory disease, diabetes, and COVID-19, on ClinicalTrials.gov and published with ≥75% US participants. We assessed language requirements frequency in eligibility criteria in publications, protocols, informed consent forms, and ClinicalTrials.gov, and readability of consent forms and eligibility criteria in protocols and ClinicalTrials.gov according to funder and disease.

Results

We report 58% of industry-funded RCTs lack mention of languages in eligibility criteria or trial documentation. The median (IQR) readability of eligibility criteria assessed with Flesch-Kincaid Grade (FKG), Gunning Fog (GF), and Simplified Measure of Gobbledygook (SMOG) is higher than the recommended eighth-grade level in protocols with FKG = 12.7 (11.0-13.9), GF = 14.5 (12.4-15.4), and SMOG = 13.7 (12.1–14.4) and ClinicalTrials.gov with FKG = 12.9 (10.8-13.9), GF = 14.0 (12.2–15.3), and SMOG = 13.9 (12.2–15.6). Informed consent forms also have reading grade levels higher than recommended for the general public, with FKG = 8.2 (7.3–9.3), GF = 9.3 (8.8-10.8), and SMOG = 10.8 (10.2-11.8).

Conclusions

Involving stakeholders during RCT design is needed to encourage explicit language reporting and high readability, which could be instrumental in RCT accessibility and equity.