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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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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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