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Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007-2024) Reported in the
Begonya Nafria1,2,3, Alexander Perera4, Segolene Gaillard5,6,7
1Patient Engagement in Research Department, Institut de Recerca Sant Joan de Déu (IRSJD), Santa Rosa 39-57, 08950, Esplugues de Llobregat, Spain. begonya.nafria@sjd.es.
Pharmaceutical Medicine
|June 22, 2026
Summary
A small percentage of European pediatric clinical trials restrict participation based on language, often without scientific justification. This can hinder cross-border access and lead to discrimination, particularly for children with rare diseases.
Area of Science:
- Clinical trial management
- Pediatric research
- Health equity
Background:
- Language diversity in Europe presents a significant barrier to cross-border clinical trial participation.
- Patients, especially children with rare diseases, may be excluded from trials due to their native language.
- Language requirements can limit access to potentially life-saving treatments for pediatric populations.
Purpose of the Study:
- To assess the frequency and scientific justification of language as an eligibility criterion in European pediatric clinical trials.
- To identify potential language-based discrimination hindering cross-border access to clinical research.
- To evaluate pediatric clinical trial protocols registered in ClinicalTrials.gov (2007-2024).
Main Methods:
- Searched 1,754 pediatric clinical trial protocols in ClinicalTrials.gov using European official languages as keywords.
- Analyzed eligibility criteria for studies conducted in Europe between 2007 and 2024.
- Defined scientific justifications for language criteria related to therapeutic areas or validated outcome measures.
Main Results:
- 95.2% of protocols did not reference European official languages in eligibility criteria.
- Only 85 protocols (4.8%) included language requirements.
- Of those with language requirements, only 27.1% (23 protocols) provided scientific justification; English and French were most common.
Conclusions:
- A minority of European pediatric studies impose language restrictions, often without clear scientific rationale.
- Recommends ethics committees require justification for language-based eligibility criteria to prevent discrimination.
- Advocates for dedicated sections on cross-border access, including resources like translations and interpreters, in trial protocols.
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