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위험 조정된 3상 임상시험×무작위 임상시험 (RCT)×
분야역학역학
계열Process / pipelineProcess / pipeline
기원 연도1980s–present1948 (first rigorously conducted RCT — MRC streptomycin trial)
창시자Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsAustin Bradford Hill; MRC Streptomycin Trial team
유형Confirmatory randomized trial with baseline risk stratification and covariate adjustmentInterventional experimental study
원전Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
별칭risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIIRCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
관련66
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.A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions.
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