KMGen: A Skill-based Approach for Synthetic Individual Patient Data Generation
Jimeng Sun · Health Innovation Professor, Siebel School of Computing and Data Science and Carle Illinois College of Medicine, University of Illinois Urbana-Champaign
Individual patient data (IPD) from clinical trials is the substrate for survival modeling, meta-analysis, and safety research, yet IPD is rarely released. Prior work has addressed only half of this gap: reconstructing Kaplan–Meier (KM) curves from published plots — typically requiring manual digitization or human-in-the-loop correction — while offering no mechanism for generating the adverse-event (AE) streams that constitute the other half of a patient record.
We introduce KMGen, the first end-to-end framework that (i) fully automates KM curve extraction at accuracy competitive with human-guided tools, and (ii) generates synthetic per-patient AE trajectories from public trial registry records. Across three held-out oncology trials spanning an order of magnitude in cohort size and 30 independent regenerations per trial, KMGen achieves mean integrated KM absolute difference ≤ 0.051, sex/ECOG JSD ≤ 0.013 on 5 of 6 demographic slots, and recovers ≥ 71% of the top-15 AEs by exact MedDRA term under a single fixed parameter set.