مقایسهٔ روشها
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| آزمایش بالینی فاز سوم تعدیلشده بر اساس ریسک× | مدل رگرسیون کوکس (Cox Proportional Hazards)× | |
|---|---|---|
| حوزه | اپیدمیولوژی | اپیدمیولوژی |
| خانواده | Process / pipeline | Process / pipeline |
| سال پیدایش≠ | 1980s–present | 1972 |
| پدیدآور≠ | Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialists | Sir David Roxbee Cox |
| نوع≠ | Confirmatory randomized trial with baseline risk stratification and covariate adjustment | Semi-parametric regression model |
| منبع بنیادین≠ | 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. DOI ↗ |
| نامهای دیگر | 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 |
| مرتبط≠ | 6 | 5 |
| خلاصه≠ | 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. |
| ScholarGateمجموعهداده ↗ |
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