Article
Considerations for the Use of AI in the Creation of Lay Summaries of Clinical Trial Results
By Kim Edwards|Jul 16, 2025
Abstract
The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial intelligence (AI). Using AI to develop lay summaries (LS) of clinical trial results can enhance transparency and accessibility, while maximising efficiencies and facilitating scalability. This document is a product of collaboration between experts from over 15 organisations in the US and the EU, including industry, academia, and a patient-focused nonprofit. It aims to explore how AI can be responsibly applied to LS development. While aligning with current industry standards, this document provides several recommendations for AI implementation that highlight the necessity of human oversight and expertise. This joint effort between human and machine can help LS achieve high standards in accuracy, transparency, and compliance, while building public trust and empowering patients to make informed healthcare decisions.
Key Takeaways:
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1.
Human Oversight Is Essential
AI can assist in drafting lay summaries, but human experts must review and refine all outputs to ensure accuracy, ethical compliance, and audience-appropriate language. AI should support, not replace, human judgment.
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2.
Transparency Builds Trust
Clear disclosure of AI involvement, including how it was used and the extent of human review, is critical for maintaining public trust, meeting regulatory requirements, and ensuring ethical communication.
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3.
Strong Governance Is Key to Safe AI Use
To use AI effectively in lay summary creation, organizations must establish clear governance frameworks. This includes managing risks like bias and misinformation, ensuring data privacy, and maintaining regulatory compliance. Continuous monitoring, prompt engineering, and expert oversight are essential to uphold quality and trust.
