Research on risk management of innovative drug clinical trials under new policies
新政策下创新药物临床试验风险管控研究

摘要

在新药审评审批制度改革深化与国际监管协调的背景下，创新药物临床试验面临着科学不确定性增强、研发进程加速与合规要求复杂等多维风险挑战。本研究系统识别并量化评估了政策驱动下的关键风险因素，涵盖方案设计、试验用药等全流程环节。基于风险评估结果，提出覆盖动态质量管理（RBM）、跨职能协作、数字化应用、政策响应等管控策略。研究表明，构建前瞻性、自适应的一体化风险管理体系，不仅是保障试验成功的技术手段，更是提升研发效率、构建监管信任与加速创新疗法可及的核心竞争力。

Abstract

Against the backdrop of deepening the reform of the new drug review and approval system and international regulatory coordination, innovative drug clinical trials face multidimensional risk challenges such as increased scientific uncertainty, accelerated research and development processes, and complex compliance requirements. This study systematically identified and quantitatively evaluated key risk factors driven by policies, covering the entire process from scheme design to experimental drug use. Based on the risk assessment results, propose control strategies such as dynamic quality management (RBM), cross functional collaboration, digital applications, and policy response. Research has shown that building a forward-looking and adaptive integrated risk management system is not only a technical means to ensure successful trials, but also a core competitiveness to improve research and development efficiency, build regulatory trust, and accelerate the accessibility of innovative therapies.