International Medical Research Frontier

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.

New policies; Innovative drugs; Clinical trials; Risk control