Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007-2024) Reported in the ClinicalTrials.gov Database.

内容摘要

One of the challenges in accessing cross-border clinical trials involving international participants in Europe is language diversity, with 32 official languages in the European continent. Some patients have reported being excluded from trials owing to their native language, and in certain studies, language has been used as an eligibility criterion for participation. Considering that pediatric studies in Europe are not conducted in all countries, cross-border access to clinical trials may represent the only therapeutic opportunity for children living with rare diseases for which no approved treatment exists. This study aimed to assess the use of language as an eligibility criterion in pediatric clinical trial protocols conducted in Europe (2007-2024) and published in the Clinicaltrials.gov database. It evaluated the frequency and context of language requirements and whether these were scientifically justified. The overall objective was to identify potential sources of language-based discrimination that may prevent cross-border access to pediatric clinical trials. The 32 official languages of the European continent were used as keywords to search the eligibility criteria of 1,754 pediatric clinical trial protocols for studies conducted in Europe between 2007 and 2024 and registered in the largest clinical trial registry, ClinicalTrials.gov, via an Application Programming Interface. Acceptable scientific justifications to use language as an eligibility criterion were defined as being (1) related to specific therapeutic areas that required language or cognitive assessments in communication with the health professionals, who do not speak the patient's language or (2) related to the use of patient- or caregiver-reported outcome measures that had only been validated in specific languages. The majority of the study protocols (95.2%) did not include any reference to European official languages in the eligibility criteria. Of the 85 study protocols that did include language requirements, only 23 (27.1%) had a scientific justification for the use of this criterion. The most frequent European languages required as eligibility criteria were English (20%) and French (16.5%). A minority of European paediatric studies (4.8%) included language in eligibility criteria in the study protocols, but of those that did, most offered no reasonable explanation for the restriction. To prevent language-based discrimination within the European regulatory framework, we recommend that ethics committees should require justification for any language-based eligibility criteria. Additionally, including dedicated sections on cross-border access in clinical trial protocols will help ensure the provision of appropriate resources such as translations, interpreters, travel, and accommodation when recruiting international participants. Pediatric clinical trials are needed to find safe and effective treatments for children. However, language requirements that are not scientifically necessary may prevent some children from taking part. In Europe, some families have reported that their child could not join a clinical trial because they did not speak a required language. This study examined 1,754 pediatric clinical trial studies conducted in Europe between 2007 and 2024, using data from a large database termed ClinicalTrials.gov. The researchers looked for any mention of language in the study entry rules (the criteria used to decide who can participate). They found that only a small number of trials (4.8%) mentioned language. However, when a language requirement was included, it was often not clearly justified. In only 27% of studies it was a scientific reason, for example, when tests required a specific language or relied on speech or understanding. English and French were the most commonly required languages. The study also identified other requirements that could limit participation, such as needing access to a mobile phone, Internet, or enrollment in a specific national health system. These factors may make it harder for international families or those with fewer resources to participate. The authors recommend that ethics committees carefully review language requirements and require a clear scientific reason before approving them. They also suggest that study plans include a section explaining how children from different language backgrounds and countries can be included.