ncreasing racial and ethnic diversity in clinical trials will facilitate the meaningful representation of different patient communities. This will contribute to delivering treatments to the market ensuring security and efficacy for wider patient groups. FDA encourages sponsors to design a Race and Ethnicity Diversity Plan at the stage of the clinical trial protocol conceptualization. This is an important step to connect the eligibility criteria considerations in clinical trials to the real prevalence of a disease.

Discrimination against potential trial participants based on language is a global problem. It prevents patients from accessing cross-border clinical trials, which would be particularly important in pediatrics due to smaller patient populations and often even fewer specialized centers. Although the European Union (EU) has a unique regulatory system for clinical trials, the 24 official languages spoken across 27 Member States make this issue even more challenging. However, participation in clinical trials in an EU Member State other than the patient’s country of residence is not included in the scope of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare.

Language discrimination in clinical trials occurs not only transnationally but also within countries. Therefore, the inclusion of patients who speak languages that are not the official ones where the clinical trial is taking place needs to be taken into consideration at the protocol design stage as well as during the conduct of the trial.

For example, in the United States (US), where English is the most commonly spoken language and the de facto national language, language discrimination is also an important issue because a considerable number of citizens are not sufficiently fluent in English. In 2014, 57 million people in the US did not speak English and an additional 25 million had limited English proficiency (LEP). According to the US Census Bureau (2015), 79.29 percent of the population speaks English at home, whereas 20.71 percent speaks a language other than English (62.06 percent of them speak Spanish).

And in Canada, where English and French are co-official national languages, the impact of language discrimination must not be underestimated. In 2016, for example, 7.7 million people (21.93 percent of the Canadian population) out of an overall population of 35.11 million reported that they speak a language other than English or French at home.

The average number of countries that in the European context are involved in clinical trials (not specifically in the pediatric setting) is 3.1 in the case of commercial sponsors and 1.2 in the case of non-commercial sponsors. Thus, the probability of having access to a pediatric clinical trial in the country where you live can be really limited.

The use of language as an eligibility criterion in clinical trials (as inclusion or exclusion criterion), often without a scientific or ethical reason, raises concerns about equity and justice. The population enrolled in clinical trials should represent the characteristics of the population that will benefit from the experimental treatments when these are approved. In this context and for pediatric clinical trials, the use of language as an eligibility criterion entails two problems:

• Firstly, it violates the principles of justice, equity, and diversity.
• Secondly, and most importantly, it violates the right of “the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health” (Article 24, UNCRC) when the only potential treatment available is the actual clinical trial and there may be a potential direct benefit to patients.

With the aim of highlighting and improving this situation in the context of pediatric clinical trials, a working group on cross-border pediatric clinical trials was established within Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) in 2022. The working group includes experts representing different stakeholders such as healthcare providers, researchers, experts in pediatric patient involvement, and clinical trial sponsors. The group aimed to analyze the state of the art of pediatric cross-border clinical trials in the EU, by collecting good practices as well as cases of language discrimination (exclusion of patients based on their mother tongue and/or country of residence).

The final aim of the working group is to provide a consensus guidance that will help to facilitate the inclusion of pediatric patients in cross-border clinical trials in the EU avoiding language discrimination. This guidance will be based on recommendations about accommodation of translation services, cultural mediators, etc., coming from the contributions of the different stakeholders (patients, parents, academia, pharma companies, ethics committees, regulatory agencies, etc.). It should be possible to easily implement the findings of this working group beyond Europe, as the same language issue exists in the USA, Canada, and other countries around the world.