A Simple Framework for Integrating AI into Real-World Evidence Generation
AI is changing how teams generate real-world evidence (RWE), but AI workflows must still produce evidence that stands up to scientific scrutiny. Realizing AI’s potential requires a clear approach to deciding which tasks agents can take on, how their work is validated, and where human-based scientific judgment is essential.
In this white paper, Datavant’s Nicolle Gatto, Katie Mues, and Ulka Campbell share a phased framework to help RWE teams:
- Identify where to introduce AI into their workflows, beginning with well-defined, rule-bound tasks.
- Clarify the roles of subject matter experts in executing, directing, and governing AI-supported workflows.
- Establish documented processes, evaluation standards, and escalation rules before expanding agents’ responsibilities.
- Prepare for the evolving role of epidemiologists as AI becomes more integrated into the workflow.

























































