arXiv:2605.13905cs.SEcs.AI2026-05

不修改旧代码,让老式药理报告系统轻松对接AI。

A Non-Destructive Methodological Framework for Modernizing Legacy Clinical Reporting Systems for AI-Driven Pharmacoinformatics: A SAS Case Study

  • 用元数据层包装旧系统,生成机器可读的中间结构
  • 558个组件、37万行代码下实现92%专有代码减少
  • 适合需合规推进AI的医药研发与监管机构

药物研发与药警监测常受制于老旧临床报告流程。这些单体系统虽满足监管要求,却因输出不透明、缺乏机器可读中间层而难以集成AI。现有现代化方案要么全重写,要么增量改造仍保留结构性障碍。本文提出一种非破坏性方法框架,无需改动旧源码即可实现面向AI的药理信息学就绪。通过引入包含桥接映射、类型化中间表示(IR)和协调器的元数据层,封装原有组件并重新暴露结构化数据,供大模型使用。支持可选的渐进式整合:部分旧组件可替换为元数据配置的核心模块,其余保持不变。在含558个组件、37.3万行代码的SAS报告库上验证,共存模式下立即实现AI就绪,输出可机器读取;选择整合后,现代核心实现92%专有代码削减。14类三期临床报告的并行验证显示,11份报告单元级一致性达80%以上(均值82.7%,最高99.2%)。基于CDISC CDISCPilot01数据的基准测试中,5份报告实现100%一致性。大模型实验表明,该框架支持自动药警分析、表格摘要与试验配置生成。本框架提供一条兼顾合规与智能化的路径,加速药物开发且不影响监管提交。

原文摘要 · Abstract (English)

Drug development and pharmacovigilance are frequently bottlenecked by legacy clinical reporting pipelines. These monolithic systems encode regulatory-grade logic but resist AI integration by producing opaque output with no machine-readable intermediate layer. Existing modernization approaches force a choice between full rewrites and incremental refactoring that preserves structural barriers. We present a non-destructive methodological framework achieving AI-driven pharmacoinformatics readiness without altering legacy source code. A metadata layer--comprising a bridge map, a typed Intermediate Representation (IR), and an orchestrator--wraps existing components and re-exposes their outputs as structured data consumable by LLMs. It enables optional incremental consolidation, replacing selected legacy components with metadata-configured core routines while the remainder operates unchanged. Validated on a 558-component SAS reporting library (373,000 lines of code), the framework demonstrated immediate AI-readiness under coexistence mode, yielding machine-readable output. Where consolidation was elected, the modernized core achieved a 92% reduction in proprietary code. Parity validation on 14 report types from a Phase III study achieved cell-level parity of 80% or above on 11 reports (mean 82.7%, best 99.2%). A benchmark using CDISC CDISCPilot01 data achieved 100% parity across 5 reports. LLM experiments confirmed the IR enables automated pharmacovigilance, table summarization, and trial configuration generation. The framework offers a regulation-aware path to AI-integrated clinical reporting, accelerating drug development without interrupting regulatory submissions.

药理信息学AI集成SAS系统合规改造

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