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Ujian Klinikal Fasa III yang Disesuaikan dengan Risiko×Regresi Bahaya Berkadaran Cox×
BidangEpidemiologiEpidemiologi
KeluargaProcess / pipelineProcess / pipeline
Tahun asal1980s–present1972
PengasasEvolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsSir David Roxbee Cox
JenisConfirmatory randomized trial with baseline risk stratification and covariate adjustmentSemi-parametric regression model
Sumber perintisPocock, 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 ↗
Aliasrisk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIICox regression, Cox PH model, proportional hazards model, CPH
Berkaitan65
RingkasanA 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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ScholarGateBandingkan kaedah: Risk-adjusted Phase III clinical trial · Cox proportional hazards. Dicapai 2026-06-20 daripada https://scholargate.app/ms/compare