EnprEMA Working Group on paediatric cross-border clinical trials
Children and young people have historically been excluded from participating in clinical research to protect them from potential harm. Nowadays, we know that it is essential to perform clinical trials with children because they suffer from diseases that adults do not suffer from and because their metabolism requires the right dose and mechanism of action for new treatments.
At present, language and country discrimination have been identified as issues that are violating the rights of children to access clinical trials in different regulatory environments. An EnprEMA WG is leading a research project on the retrospective analysis of the design and execution of paediatric clinical trials in Europe as a research setting during the period 2017-2021. The main aim is to perform an evidence-based analysis to deliver a 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 native language or country of residence.
This project will consist of three phases.
The first phase will analyse the use of language and country of residence in clinical trial protocols as exclusion criteria. Real cases reported 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 will be provided as supporting evidence.
The second phase will analyse the scientific and ethical reasons behind the use of language and country of residence to exclude patients from participating in a clinical study.
Finally, a multi-stakeholder consensus guideline will be delivered in the third phase 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).
The data collection of the EnprEMA WG is based on the contributions of professionals from Clinical Research Units and parents of children living with a disease. This phase of the work is open to all the sites and professionals interested in sharing good practices and reporting cases of language discrimination, that will facilitate a scientific and ethics assessment.
If you are interested in contributing to this research project, as medical expert or parent, please complete the relevant survey below:
If you are from a clinical research unit, complete this survey.
If you are a patient or parent, complete this survey.
If you have any questions about the project, please contact Begonya Nafria, Chair of the EnprEMA Working Group, at begonya.nafria@sjd.es.
