SIG: Real-World Evidence (RWE) Collaborative

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Milestone Achieved: Protocol Finalized and Registered for Generative AI and RWE Review

  • 1.  Milestone Achieved: Protocol Finalized and Registered for Generative AI and RWE Review

    Posted 07-25-2025 14:03
    Hi all, please see below update message on this exciting project:
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    Dear colleagues,
     
    We are pleased to share an exciting milestone from the Innovative Topics Working Group within the RWE Collaborative SIG. Our team has finalized the protocol titled:
    "Applications of Generative Artificial Intelligence for Real-World Evidence Generation: A Protocol for a Living Scoping Review"
     
    Now registered on OSF and PROSPERO (link to be shared separately) marking a significant step forward in this important initiative, this living scoping review will explore GenAI applications across the RWD-to-RWE continuum, addressing key questions such as:
    🔹 How is GenAI being used for RWE generation? What are the common use cases and tasks areas?
    🔹 What GenAI models are being used? How are they trained, and on what types of data?
    🔹 What are the limitations and risks? From data bias to transparency, we'll assess the challenges.
    🔹 How well does GenAI perform? We'll examine credibility, accuracy, and how performance is being evaluated.
    🔹 What trends and patterns are emerging for real world research across the product lifecycle? And where are there untapped opportunities?
     
    We're pleased with our progress and are now gearing up to kick off the review. Stay tuned for updates as we dive deep into how GenAI is reshaping the future of real-world evidence.
    Should you have any questions or wish to learn more, please don't hesitate to reach out to Nivi (nivantha.naidoo@oracle.com) or John (john.diaz-decaro@modernatx.com)
     
    Best regards,
    Nivantha Naidoo
    On behalf of the authorship team and the Innovative Topics Working Group
    RWE Collaborative SIG

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    John Diaz-Decaro
    Vice Chair- ISPE Digital Epidemiology SIG
    Sr. Director, Epidemiology Latent Viruses (EBV)
    ModernaTX, Inc.
    Cambridge, MA
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