The European Network of Paediatric Research at the EMA (EnprEMA) has launched a public consultation on its draft recommendations, Cross-Border Access to Paediatric Clinical Trials in Europe: Preventing Language Exclusion.
The draft recommendations examine how language and logistical barriers continue to limit children’s participation in clinical research across Europe, despite existing legislation prohibiting discrimination. They summarise current evidence showing that insufficient translation resources, a lack of validated translated study materials, and implicit language requirements may restrict access to innovative therapies — particularly for children with rare diseases who may need to travel abroad to participate in clinical trials.
EnprEMA invites comments from the wider paediatric research community, including clinical trial sites, investigators, research networks, sponsors, patient organisations, and families. Feedback will help identify gaps, strengthen the recommendations, and ensure they reflect both available evidence and practical experience.
Deadline: Submit comments by September 30, 2026, using the consultation template, sent to enprema@ema.europa.eu.
Following the consultation, EnprEMA will review all comments and publish a revised version of the recommendations.
