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ClinAgent: A Five-Layer Architecture for Autonomous Clinical Trial Statistical Programming

2026-01-16 health informatics Title + abstract only
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Clinical trial statistical programming requires 12-24 FTE-months for a typical Phase 3 study, producing 100-500 tables, listings, and figures (TLFs) across 8-15 ADaM domains. Modern AI coding agents (Augment Code, Claude Code, Cline, Cursor) demonstrate remarkable reasoning capabilities but lack the domain-specific tools needed for clinical programming: they cannot read SAS datasets, parse ADaM specifications, analyze regulatory-relevant log issues, or generate CDISC-compliant code without exten...

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