GxP-Agent: Process-DAG Topology for Reliable Clinical Trial Programming with LLM Agents: Clinical trial programming...
Transforming study protocols into analysis-ready datasets under CDISC standards -- is a bottleneck in regulatory submissions, yet LLM-based code generation fails catastrophically on this task: across 11 single-shot attempts with five frontier models, none produces a valid subject-level analysis dataset. We introduce GxP-Agent...
Source Brief
GxP-Agent: Process-DAG Topology for Reliable Clinical Trial Programming with LLM Agents: Clinical trial programming -- transforming study protocols into analysis-ready datasets under CDISC standards -- is a bottleneck in regulatory submissions, yet LLM-based code generation fails catastrophically on this task: across 11 single-shot attempts with five frontier models, none produces a valid subject-level analysis dataset. We introduce GxP-Agent...