AI is playing a growing role in real-world evidence, but not all AI serves the same purpose. Two terms often used interchangeably, Generative AI and Agentic AI, describe very different capabilities and the distinction matters in real-world evidence (RWE) settings.
Generative AI (GenAI) produces outputs in response to a prompt. In RWE, it’s already helping teams draft analysis code, summarize data, extract signals from unstructured text and move through early exploration faster. GenAI is reactive. It accelerates work, but it doesn’t decide what to do next.
Agentic AI, by contrast, is goal-driven. It can plan, sequence and execute multiple steps toward an objective, iterating on analyses, triggering follow-on actions or coordinating tools without direct human prompting. That autonomy can be powerful, but it also introduces risk when evidence needs to be transparent and defensible so building guardrails and transparency into these tools becomes important. HealthVerity eXOs is an example of agentic AI purpose-built for emerging and small biopharma using RWE.
|
Generative AI (GenAI) in RWE |
Agentic AI in RWE |
|
|---|---|---|
|
Content and outputs |
Produces outputs in response to a prompt |
Produces analysis and insights. Plans and executes multi-step analyses toward a defined objective |
|
Workflow role |
Assists with discrete tasks such as drafting code or summaries |
Users define the objective, and the agent plans and coordinates query validation, data extraction, statistical planning required to complete the objective |
|
Level of autonomy |
Reactive, responds only to prompts given, may ask follow-up questions to suggest next steps |
Goal-driven with structured execution. Moves through a sequence of predefined steps that reflect how RWE studies are carried out |
|
Human involvement |
User prompts and reviews each output |
Human-in-the-loop checkpoints with validation of query before execution of steps |
|
Typical RWE use cases |
Code drafting, summarization, exploration, technical writing |
Feasibility, prevalence, adherence, time-to-event and comparative outcomes |
This distinction matters because RWE is judged not just on speed but on traceability, and complete transparency. As AI systems gain more autonomy, it becomes harder to explain how results were generated unless governance, oversight and auditability are built in from the start.
For RWE teams, the priority shouldn’t be replacing analysts with AI. It should be using AI to augment expert judgment, enabling teams to answer more questions quickly and with greater analytical depth. AI can surface latent cohorts that researchers may have overlooked and uncover more comprehensive code sets, giving humans better inputs for decision-making. That’s especially important as AI begins influencing early stage decisions like cohort definition, protocol shaping and whether to advance a preliminary study.
It’s also worth stating plainly: neither GenAI nor agentic AI can compensate for weak data foundations. Poor linkage, incomplete longitudinal data or unclear provenance will undermine results, often faster, when AI is layered on top.
GenAI helps teams move faster. Agentic AI enables systems to do more on their own. In RWE, speed matters, but confidence matters more. The organizations that succeed will apply AI in ways that preserve rigor, transparency and human judgment rather than optimizing for autonomy alone. Importantly, agentic AI in RWE isn’t designed to replace human expertise. It’s meant to fit into existing workflows by automating repeatable steps, reducing analytical backlog and accelerating time to insight so teams can focus on higher-value, strategic questions. When applied with clear guardrails and human oversight, AI becomes a productivity multiplier.
If you’re exploring how to apply AI responsibly in real-world evidence, we’ve put together a practical guide on how to write effective prompts designed specifically for data, analytics and RWE use cases and what that looks like using our own tool, HealthVerity eXOs or download our latest guide to learn about the types of prompts you can answer with HealthVerity eXOs: The Anatomy of Good AI Prompt.