Global Working Group Releases Publication on Responsible Use of Artificial Intelligence in Creating Lay Summaries of Clinical Trial Results

New publication underscores the importance of human oversight, transparency, and patient involvement in AI-assisted lay summaries.

BOSTON, Sept. 4, 2025 /PRNewswire/ -- The Center for Information and Study on Clinical Research Participation (CISCRP) today announced the publication of a landmark article, "Considerations for the Use of Artificial Intelligence in the Creation of Lay Summaries of Clinical Trial Results" , in Medical Writing (Volume 34, Issue 2, June 2025). Developed by the working group, Patient-focused AI for Lay Summaries (PAILS) , this comprehensive document addresses both the opportunities and risks of using artificial intelligence (AI) in the development of plain language communications of clinical trial results.

Lay summaries (LS) are essential tools for translating complex clinical trial results into plain language that is clear, accurate, and accessible to patients, caregivers, and the broader community. As AI technologies evolve, they hold promise for streamlining LS creation, improving efficiency, and expanding access to trial results. However, without thoughtful integration and oversight , AI-generated content can risk inaccuracies, cultural insensitivity, and loss of public trust.

For biopharma sponsors, CROs, and medical writing vendors, this framework offers clear, best practices for integrating AI responsibly while maintaining compliance with EU and UK lay summary regulations and improving efficiency at scale.

Key recommendations from the working group include:

• Human oversight is essential – AI should support, not replace, expert review to ensure accuracy, clarity, and cultural sensitivity.
• Prompt Engineering is a Critical Skillset – Thoughtful, specific prompts – including instructions on tone, reading level, terminology, structure, and disclaimers – can make the difference between usable and unusable drafts.
• Full transparency of AI involvement – Disclosing when and how AI was used builds public trust and complies with emerging regulations such as the EU Artificial Intelligence Act.
• Robust governance frameworks – Policies should address bias, privacy, compliance, and ongoing monitoring of AI systems.
• Patient and public involvement – Including patient perspectives in review processes improves relevance and comprehension.

"This considerations document is the result of thoughtful collaboration among industry, academia , and CISCRP." said Kimbra Edwards, Senior Director of Health Communication Services at CISCRP. "By combining human expertise with AI innovation, we can ensure that clinical trial information remains transparent, accurate, and truly patient-centered."

PAILS Working Group Members Representing Over 15 Organizations with Global Perspectives

PAILS represented a cross-section of the research ecosystem—sponsors, tech platforms, CROs, writers, and patient advocates—underscoring the broad relevance of the recommendations :

Sanjay Bagani (Xogene), Behtash Bahador (CISCRP), Sudipta Chakraborty (Biogen), Kimbra Edwards (CISCRP), Julia Farides-Mitchell (CISCRP), Zack Fey (CISCRP), Ken Getz (CISCRP/Tufts CSDD), Julie Holtzople (Independent Consultant), Jennifer Menzer (Merck Healthcare KGaA), Anne McClain (UCB), Madison Reider (CSL Behring), Malgorzata Sztolsztener (AstraZeneca), Woo Song (Xogene), Jamila Watkins (Clinical Ops & Patient Engagement Expert), Kristi Whiteside (Clinical Trial Transparency Expert).

The article is now available online through Medical Writing and serves as a practical framework for integrating AI into patient communications while maintaining the highest ethical and scientific standards.

To read the full publication or discuss how your team can responsibly integrate AI into clinical trial communications, contact us or View the publication here.

CISCRP ('sys-krip') (Center for Information and Study on Clinical Research Participation) is a globally recognized nonprofit dedicated to educating the public, supporting sponsors in clinical trial transparency, and engaging patients as partners throughout the research process. Through services like plain language summary development, patient advisory boards, and global educational programs, CISCRP works across 45+ countries to strengthen trust and improve health literacy. Organizing and leading this effort aligns with CISCRP expertise and forward-thinking in patient engagement and underscores the role and of emerging technologies across stakeholder's om research, from sponsors and CROs to medical writing and patient communication teams.

SOURCE CISCRP