用智能体自动优化临床试验方案,提升成功率且成本极低
ClinicalReTrial: Clinical Trial Redesign with Self-Evolving Agents
- 构建多智能体系统,闭环迭代改进试验文本方案
- 83.3%方案优化成功,平均成功率提升5.7%,每轮仅需0.12美元
- 可发现真实世界中有效的调整策略,适合药物研发人员
临床试验是药物研发的关键环节,但成本高昂(平均每药26亿美元),且协议以复杂自然语言文档形式存在,亟需超越人工分析的AI系统。现有方法虽能准确预测试验失败,但无法提供可操作的改进方案。本文提出ClinicalReTrial,一种多智能体系统,将试验优化建模为文本协议的迭代重设计问题。该方法在闭环、奖励驱动框架中集成失败诊断、安全感知修改与候选评估。以结果预测模型作为仿真环境,实现低成本评估和密集奖励信号,支持持续自我优化。我们进一步设计分层记忆机制,捕捉试验内迭代反馈,并提炼跨试验可迁移的重设计模式。实验表明,ClinicalReTrial使83.3%的试验方案得到改进,平均成功率提升5.7%,单次成本仅为0.12美元。回顾性案例研究显示,所发现的优化策略与真实世界临床试验调整高度一致。代码已匿名公开于:https://github.com/xingsixue123/ClinicalFailureReasonReTrial。
原文摘要 · Abstract (English)
Clinical trials constitute a critical yet exceptionally challenging and costly stage of drug development (\$2.6B per drug), where protocols are encoded as complex natural language documents, motivating the use of AI systems beyond manual analysis. Existing AI methods accurately predict trial failure, but do not provide actionable remedies. To fill this gap, this paper proposes ClinicalReTrial, a multi-agent system that formulates clinical trial optimization as an iterative redesign problem on textural protocols. Our method integrates failure diagnosis, safety-aware modifications, and candidate evaluation in a closed-loop, reward-driven optimization framework. Serving the outcome prediction model as a simulation environment, ClinicalReTrial enables low-cost evaluation and dense reward signals for continuous self-improvement. We further propose a hierarchical memory that captures iteration-level feedback within trials and distills transferable redesign patterns across trials. Empirically, ClinicalReTrial improves $83.3\%$ of trial protocols with a mean success probability gain of $5.7\%$ with negligible cost (\$0.12 per trial). Retrospective case studies demonstrate alignment between the discovered redesign strategies and real-world clinical trial modifications. The code is anonymously available at: https://github.com/xingsixue123/ClinicalFailureReasonReTrial.
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