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Evolving AI Use in Clinical Trials

In a groundbreaking publication from the Center for Information and Study on Clinical Research Participation (CISCRP), the working group known as Patient-focused AI for Lay Summaries (PAILS) has released a document titled "Considerations for the Use of Artificial Intelligence in the Creation of Lay Summaries of Clinical Trial Results". Published in the June 2025 issue of Medical Writing, this comprehensive resource scrutinizes the transformative role that artificial intelligence (AI) can play in effectively communicating clinical trial outcomes to a wider audience.

The Significance of Lay Summaries

Lay summaries (LS) act as essential bridges between complex clinical trial results and the general public, including patients and caregivers. These summaries aim to present scientific data in a format that is clear, accurate, and easily digestible. As AI technologies become more sophisticated, they offer promising avenues for enhancing the efficiency of lay summary production, ultimately broadening access to critical health information. However, the risks associated with AI-generated content must be carefully evaluated to avoid inaccuracies, cultural misunderstandings, and a subsequent erosion of public trust.

Key Recommendations from PAILS

The document presents a framework of best practices for the responsible integration of AI into the lay summary development process. Here are some of the key recommendations put forth by the working group:

1. Human Oversight is Crucial

While AI can assist in drafting lay summaries, it should never replace the need for expert human review. Human oversight is essential to ensure that the output meets standards of accuracy, clarity, and cultural appropriateness.

2. Importance of Prompt Engineering

The effectiveness of AI-generated drafts largely depends on prompt engineering. Providing specific instructions regarding tone, reading level, terminology, and structure can mean the difference between useful and ineffective summaries.

3. Transparency in AI Involvement

Disclosing the role of AI in producing lay summaries is critical for building public trust and complying with regulations, such as the EU Artificial Intelligence Act. Transparency not only promotes ethical standards but also aligns with the movement toward greater accountability in AI applications.

4. Robust Governance Frameworks

Organizations should implement policies to address potential biases, protect privacy, ensure compliance, and monitor the functioning of AI systems continuously. Effective governance frameworks will help in maintaining stakeholder trust and in mitigating risks associated with AI technology.

5. Engaging Patients and the Public

Involving patients in the review process enhances the relevance of lay summaries. Their insights can significantly improve comprehension and connection with the broader community.

Collaborative Efforts

As Kimbra Edwards, Senior Director of Health Communication Services at CISCRP, noted, this document arises from comprehensive collaboration among various stakeholders, including industry professionals, academic experts, and patient advocates. The diverse backgrounds of the PAILS working group members emphasize the broad relevance of the recommendations. List of contributors includes:

• - Sanjay Bagani (Xogene)
• - Behtash Bahador (CISCRP)
• - Sudipta Chakraborty (Biogen)
• - Kimbra Edwards (CISCRP)
• - And others from leading firms...

Conclusion

This publication signifies a vital shift in the approach to communicating clinical trial results, outlining how human expertise synergizes with AI to ensure that information remains trustworthy, accurate, and centered around patient needs. The article is now available online and provides a solid foundation for companies aiming to responsibly integrate AI into their clinical trial communications.

For organizations seeking to improve their processes, CISCRP offers resources and support to guide them in implementing these best practices effectively. To explore the full publication or discuss strategies for responsible AI integration in clinical trial communications, visit the CISCRP website for more information.