方法对比

	自适应竞争风险分析	自适应试验设计
领域	流行病学	临床研究
方法族	Process / pipeline	Process / pipeline
起源年份	1999 (foundational Fine-Gray model); adaptive extensions 2000s–2010s	1990s-2000s
提出者	Fine & Gray (subdistribution hazard, 1999); adaptive extensions by Beyersmann, Schumacher and colleagues	Stephen Pocock, Christopher Jennison, and statistical methodologists; FDA formalized guidance 2019
类型	Statistical survival analysis with adaptive interim monitoring	Research Design
开创性文献	Fine, J. P., & Gray, R. J. (1999). A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association, 94(446), 496–509.	Pocock, S. J. (2005). Current issues in the design and interpretation of clinical trials. BMJ, 330(7500), 1118–1121.
别名	adaptive Fine-Gray analysis, group-sequential competing risks, adaptive subdistribution hazard analysis, competing risks adaptive design	adaptive trial, adaptive design, response-adaptive randomization, RAR
相关	2	1
摘要	Adaptive competing risks analysis combines the Fine-Gray subdistribution hazard framework — which models the cumulative incidence of one cause of failure in the presence of other mutually exclusive causes — with adaptive or group-sequential interim monitoring rules. This allows a clinical trial or observational study to be modified mid-course (e.g., sample size reassessment, early stopping) based on accumulating competing-risk data while maintaining pre-specified type I error control.	An adaptive trial design allows pre-specified modifications to the trial based on interim data—such as sample size re-estimation, stopping for futility or efficacy, dropping ineffective arms, or shifting randomization ratios toward better-performing treatments. Developed systematically in the 1990s–2000s by statisticians like Pocock and Jennison, and formalized by the FDA in 2019, adaptive designs accelerate drug development, reduce exposure to ineffective treatments, and improve efficiency without inflating false-positive rates when properly executed.