Plain Language Summaries

The EU Clinical Trial Regulation mandates lay summaries within 12 months of trial completion (6 months for pediatric trials), with a three-year phase-in period making submission mandatory by 2025. There has been growing emphasis on AI-assisted drafting while maintaining transparency and oversight. Key trends include standardizing patient-facing documents, improving dissemination strategies to study participants, and ensuring consistency across multiple public-facing materials. Organisations are balancing outsourcing versus internal development to meet mounting disclosure requirements while protecting confidential information and achieving global registry compliance.