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Considerations for Using AI to Create Lay Summaries of Trial Results

Public Comment is open on our draft Considerations Document until February 18, 2025. Provide your feedback to help establish the considerations for using AI to create lay summaries.

Lay summaries (LS) are essential for making clinical research results more transparent and accessible to non-scientists, addressing the traditional barrier of complex scientific language. Artificial Intelligence (AI) has the potential to streamline the drafting of LS, saving time and resources. However, overreliance on AI to generate these summaries without appropriate human oversight can lead to inaccuracies or misinterpretations. Currently, no guidelines exist for the responsible use of AI in creating LS or other patient-friendly clinical research information.

Developing the Considerations Document

This draft document was developed over an extended consultative process involving more than 15 organizations from the US and EU including industry, academia, and CISCRP. The individuals involved in the collaboration represent clinical trial transparency industry experts with diverse backgrounds in medical writing, technology, clinical operations, plain language, and patient engagement. The work group is committed to ensuring accurate and appropriate use of AI in creating LS.

Work Group Members
  • Sanjay Bagani, Vice President, Clinical Trials Transparency, Xogene  
  • Behtash Bahador, Director, Health Literacy, CISCRP 
  • Sudipta Chakraborty, Clinical Trial Transparency Lead, Biogen  
  • Kim Edwards, Senior Director, Health Communication Services, CISCRP 
  • Julia Farides-Mitchell, Director, Health Communication Services, CISCRP 
  • Zack Fey, Manager, Medical Writing, CISCRP 
  • Ken Getz, Founder, Board Chair CISCRP; Director, Tufts CSDD 
  • Julie Holtzople, Independent Consultant, Clinical Trial Transparency Expert 
  • Jennifer Menzer, Senior Expert Clinical Trial Transparency, Merck Healthcare KGaA  
  • Anne McClain, Transparency Operations Lead, UCB 
  • Madison Reider, Senior Manager, R&D Patient Partnerships, CSL Behring 
  • Malgorzata Sztolsztener, Director, Clinical Trial Transparency Patient Engagement, AstraZeneca 
  • Woo Song, Co-founder, Xogene  
  • Jamila Watkins, Clin-Ops, Patient, Site & Community Engagement Expert 
  • Kristi Whiteside, Clinical Trial Transparency Expert 

Inviting Public Feedback

We want to ensure the best possible applicability and use of this document, through engagement and feedback from other individuals and organizations with experience, expertise and insights from across disciplines and stakeholder groups, including research professionals, the public, patients, advocates and any other reviewer who provides comment.

Complete our online survey to provide open response comments to our Considerations Document.