Begonya Nafria Escalera
Begonya Nafria
Share4Rare Coordinator

Language discrimination in the access of children living with rare diseases to cross-border clinical trials in Europe

europe languages clinical trials children share4rare
Children and young people have often been excluded from clinical research to protect them from potential harm. However, we know now that paediatric clinical trials are essential because they suffer from diseases that adults do not, and their unique metabolism requires specific doses and mechanisms for new treatments.

Language and country discrimination to access clinical trials have been identified as issues that violate children's rights in different regulatory environments. An EnprEMA working group is leading a research project analysing the design and execution of pediatric clinical trials in Europe from 2017 to 2021. The main goal is to perform an evidence-based analysis to deliver consensus guidance that will facilitate the inclusion of paediatric patients in cross-border clinical trials when there is a potential benefit, and not exclude them due to their mother tongue or country of residence.

Project phases

The project consists of three phases:

  1. The first phase will analyse the use of language and country of residence in clinical trial protocols as exclusion criteria. Real cases will be provided as supporting evidence by clinical trial sites, patients, and patient organisations, where mother tongue and country of residence were used to discriminate against patients’ access to a clinical trial.
  2. The second phase will analyse the scientific and ethical reasons behind using language and country of residence to exclude patients from participating in a clinical study.
  3. Finally, on the third phase, a multi-stakeholder consensus guideline will be delivered to avoid future discrimination against paediatric patients accessing clinical trials in Europe. This guidance will be co-created with multi-stakeholders and validated after a public consultation. The outcomes of this research may also benefit other regulatory environments beyond Europe (e.g. USA/Canada).

Please, help us by completing this survey:

Parents and caregivers of children with a rare disease can also participate in this project by completing this brief questionnaire. It will only take 10 minutes to complete. No previous experience in clinical trials is necessary.

*If you would like to know more about this research project, as a medical expert or a parent, you can contact Begonya Nafria, Chair of the Enpr-EMA Working Group and Coordinator of the Share4Rare platform, at begonya.nafria@sjd.es.

 

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