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Key insights from my presentation at the AMWA Carolinas Spring 2026 Conference on the evolving global expectations for patient-facing clinical content
Lay language is experiencing one of the most important shifts in modern regulatory writing.
What was once viewed primarily as a compliance requirement is now becoming a strategic priority across clinical development and operations and regulatory affairs. Global health authorities increasingly expect patient-facing clinical content to be clear, accessible, and inclusive for broader audiences.
During my presentation at the AMWA Carolinas Spring 2026 Conference, I explored how evolving regulations, transparency initiatives, and health literacy expectations are reshaping the future of lay summaries and patient-centered communication.
Why Lay Language Matters More Than Ever
The European Union Clinical Trials Regulation (EU CTR) continues to set the global benchmark for lay language trial summary requirements. Sponsors conducting interventional clinical trials through the Clinical Trials Information System (CTIS) must provide lay summaries within defined timelines following study completion based on the age of study participants.
At the same time, expectations are expanding beyond compliance alone. Health authorities and healthcare organizations increasingly expect communication that not only meets regulatory requirements but also enables patients to understand and use the information being provided, supporting:
• Health literacy
• Accessibility
• Cultural inclusivity
• Language equity
This shift is redefining how regulatory writing teams approach patient-facing clinical trial communications.
Key Trends Reshaping Regulatory Writing and Lay Language Summaries
Visual communication is becoming essential
Medical writers and sponsors are moving beyond text-heavy summaries and incorporating:
• Infographics
• Patient-friendly graphics
• Educational videos
• Visual storytelling
• Structured content layouts
The thoughtful use of visuals can help simplify complex scientific information, improve readability, and increase engagement among non-specialist audiences.
Readability and accessibility are now quality standards
Plain language principles are becoming central to modern medical writing workflows. Organizations are prioritizing:
• Clear sentence structure
• Simplified terminology
• Accessible formatting
• Audience-focused messaging
Readability is no longer viewed as an enhancement. It is becoming an essential quality metric for regulatory and patient-facing content.
Multilingual consistency is a growing priority
As global clinical trials continue to expand, organizations are placing greater focus on ensuring consistency across languages, regions, and regulatory submissions.
Translation strategies are evolving into broader governance frameworks that support clarity, accuracy, and alignment across global markets.
AI and structured workflows are reshaping regulatory writing
Medical writing teams are increasingly adopting:
• Template-driven authoring
• Controlled terminology
• Structured content workflows
• Artificial intelligence-assisted predrafting
These approaches support consistency, scalability, and efficiency across regulatory writing and lay language summary development.
What This Means for Medical Writing Teams
The role of the medical writer continues to evolve beyond document creation.
Today’s regulatory writing professionals are expected to contribute to:
• Patient engagement strategies
• Health literacy initiatives
• Accessibility planning
• Global content alignment
• Inclusive communication practices
Organizations that invest in standardized workflows and patient-centered communication strategies will be better positioned to meet evolving global expectations.
Lay language is no longer a secondary activity. It is becoming a visible indicator of communication quality, transparency, and organizational maturity.
Ready to Strengthen Your Lay Language Strategy?
As global expectations for patient-facing clinical content continue to evolve, organizations need regulatory writing partners who understand both compliance and communication.
Our regulatory writing and medical communications experts support:
• Lay summaries and patient-facing clinical content
• EU CTR and global transparency compliance
• Plain language and health literacy optimization
• Multilingual regulatory communications
• Accessibility-focused content development
• Medical writing workflow strategy and scalability
If you need to create lay language documents for clinical trials, contact our team of experts to build clear, compliant, and patient-centered regulatory communications with confidence.
Laura Sheppard, MBA, MA
Senior Director / Service Line Head, Clinical Regulatory Writing North America, Lay Language Writing, and Strategic Relationship Management
Ms. Sheppard is Senior Director and Service Line Head of Clinical Regulatory Writing North America, Lay Language Writing, and Strategic Relationship Management at Veristat. She has 20 years of experience in translational science, clinical development, and clinical operations, including 15 years in medical and lay language writing, regulatory strategy, document quality review, and leadership across CRO and pharmaceutical settings.
She leads teams of regulatory writers and collaborates with cross-functional stakeholders to support global development programs. Her expertise includes regulatory submissions for biologics and small molecules, including INDs, NDAs, BLAs, MAAs, and CTAs.
Ms. Sheppard served three consecutive terms as Director-at-Large for the American Medical Writers Association (AMWA) and currently serves as Program & Events Chair and 2027 President-Elect/Vice President of the AMWA Delaware Valley Chapter. Her therapeutic experience spans anti-infectives, cardiovascular, CNS, endocrinology, gastroenterology, immunology, nephrology, neuroscience, oncology, rare diseases, respiratory, urology, and xenotransplantation.