系统梳理药物临床试验全流程及技术变革趋势。

Clinical trials are an indispensable part of the drug development process, bridging the gap between basic research and clinical application. During the development of new drugs, clinical trials are used not only to evaluate the safety and efficacy of the drug but also to explore its dosage, treatment regimens, and potential side effects. This review discusses the various stages of clinical trials, including Phase I (safety assessment), Phase II (preliminary efficacy evaluation), Phase III (large-scale validation), and Phase IV (post-marketing surveillance), highlighting the characteristics of each phase and their interrelationships. Additionally, the paper addresses the major challenges encountered in clinical trials, such as ethical issues, subject recruitment difficulties, diversity and representativeness concerns, and proposes strategies for overcoming these challenges. With the advancement of technology, innovative technologies such as artificial intelligence, big data, and digitalization are gradually transforming clinical trial design and implementation, improving trial efficiency and data quality. The article also looks forward to the future of clinical trials, particularly the impact of emerging therapies such as gene therapy and immunotherapy on trial design, as well as the importance of regulatory reforms and global collaboration. In conclusion, the core role of clinical trials in drug development will continue to drive the progress of innovative drug development and clinical treatment.