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Simulation technology is an effective tool to improve the success rate of clinical studies, with applications at all stages of clinical research. This paper illustrated the content, requirements, and issues in three parts: simulation plan, implementation, summary, and evaluation. In the case practice of survival analysis, the article assumed a scenario where time-to-event data does not meet the proportional hazards assumption, using an exponential cure rate function model with a delayed effect. The simulation aimed to study trial design factors such as the average hazards ratio, sample size, and number of events. The results demonstrated that non-proportional hazards assumptions significantly impact the trial hypothesis, follow-up time, and analysis time. Using normal trial design methods based on the proportional hazards assumption could lead to reduced test power and unreliable interim analysis results. Simulation technology could better support the design and implementation of clinical trials. Finally, the paper discussed the importance and impact of scenario assumption in simulation implementation and execution. Also, it is pointed out that the complexity of simulation should be considered to improve the feasibility of simulation execution.

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模拟技术是提高临床试验成功率的重要工具，且在临床研究各阶段中均有重要作用。本文阐述了模拟计划方案、执行、总结和评价3部分中的内容、要求和需关注的问题。在以生存分析的应用实践中，本文假设的情景为不符合等比例风险假设的时间事件数据，使用的模型为包含延滞效应的指数治愈率函数模型，模拟目的是对平均风险比、样本量、事件数等试验设计因素进行研究。模拟结果显示，非等比例风险假设对于试验假设、随访时间和分析时间均有重要影响。使用等比例风险假设下的试验设计方法会造成试验检验把握度降低、不可靠的期中分析结果等问题，而模拟技术可以更好地支持临床试验的设计和实施。最后讨论了模拟实施中情景假设的重要程度和对模拟执行的影响，并指出应考虑模拟的复杂度以提高模拟执行的可行性。

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李若冰，男，助理研究员，主要从事药品的技术审评工作。联系电话：(010)85243215，E-mail: lirb@cde.org.cn。

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李若冰，男，助理研究员，主要从事药品的技术审评工作。联系电话：(010)85243215，E-mail: lirb@cde.org.cn。

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