方法对比

	自适应竞争风险分析	自适应试验设计	生存分析
领域	流行病学	临床研究	研究统计学
方法族	Process / pipeline	Process / pipeline	Process / pipeline
起源年份	1999 (foundational Fine-Gray model); adaptive extensions 2000s–2010s	1990s-2000s	1958
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	Edward L. Kaplan and Paul Meier
类型	Statistical survival analysis with adaptive interim monitoring	Research Design	Method
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.	Kaplan, E. L., & Meier, P. (1958). Nonparametric estimation from incomplete observations. Journal of the American Statistical Association, 53(282), 457–481.
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	Kaplan-Meier analysis, Cox regression, TTE analysis
相关	2	1	3
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.	Survival analysis is a collection of statistical methods for modeling time from a defined starting point until an event of interest occurs (disease, recovery, death, equipment failure). Kaplan and Meier's nonparametric estimator (1958) and David Cox's proportional hazards model (1972) jointly enabled analysis of censored data—individuals whose event times are unknown because they left the study or were still event-free at follow-up. Indispensable in oncology, cardiology, infectious disease research, engineering reliability, and any field where time-to-event matters.