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위험 조정된 3상 임상시험×Cox 비례 위험 모형×
분야역학역학
계열Process / pipelineProcess / pipeline
기원 연도1980s–present1972
창시자Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsSir David Roxbee Cox
유형Confirmatory randomized trial with baseline risk stratification and covariate adjustmentSemi-parametric regression model
원전Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556Cox, D. R. (1972). Regression models and life-tables. Journal of the Royal Statistical Society: Series B (Methodological), 34(2), 187–202. DOI ↗
별칭risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIICox regression, Cox PH model, proportional hazards model, CPH
관련65
요약A 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.
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