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	リスク調整型第III相臨床試験	Cox Proportional Hazards
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1980s–present	1972
提唱者	Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialists	Sir David Roxbee Cox
種類	Confirmatory randomized trial with baseline risk stratification and covariate adjustment	Semi-parametric regression model
原典	Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556	Cox, D. R. (1972). Regression models and life-tables. Journal of the Royal Statistical Society: Series B (Methodological), 34(2), 187–202.
別名	risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase III	Cox regression, Cox PH model, proportional hazards model, CPH
関連	6	5
概要	A risk-adjusted Phase III clinical trial is a large-scale confirmatory randomized experiment that explicitly incorporates participants' baseline prognostic risk profile into both the randomization process and the primary statistical analysis. By stratifying patients on known risk factors before allocation and adjusting for those factors in the outcome model, the design achieves greater statistical precision, reduces confounding, and produces treatment effect estimates that are more clinically meaningful across patient subgroups.	The Cox proportional hazards model is a semi-parametric regression method that estimates the effect of one or more covariates on the hazard — the instantaneous rate of an event such as death, relapse, or failure — while making no assumption about the shape of the baseline hazard function. Introduced by David Cox in 1972, it is the dominant tool for multivariable survival analysis in clinical and epidemiological research.