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Thử nghiệm lâm sàng Giai đoạn III điều chỉnh theo rủi ro×Cox proportional hazards×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1980s–present1972
Người khởi xướngEvolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsSir David Roxbee Cox
LoạiConfirmatory randomized trial with baseline risk stratification and covariate adjustmentSemi-parametric regression model
Công trình gốcPocock, 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 ↗
Tên gọi khácrisk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIICox regression, Cox PH model, proportional hazards model, CPH
Liên quan65
Tóm tắtA 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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ScholarGateSo sánh phương pháp: Risk-adjusted Phase III clinical trial · Cox proportional hazards. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare