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自适应病例系列×自适应随机临床试验×
领域流行病学流行病学
方法族Process / pipelineProcess / pipeline
起源年份Late 20th–early 21st centuryLate 1990s–2000s (widespread adoption post-2010)
提出者Evolved from classical case series methodology combined with adaptive design principles (Chow & Chang, 2008; FDA adaptive design guidance)Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
类型Observational study with adaptive monitoringExperimental clinical trial design
开创性文献Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887775Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
别名adaptive case-series design, sequential adaptive case series, adaptive observational case seriesadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
相关56
摘要An adaptive case series is an observational study design that documents a consecutive group of patients with a shared condition or exposure while incorporating pre-specified rules for modifying data collection, monitoring, or stopping criteria as accumulating evidence warrants. It combines the descriptive richness of traditional case series with the prospective flexibility of adaptive design principles, enabling structured mid-course adjustments without compromising the integrity of the recorded clinical observations.An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.
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ScholarGate方法对比: Adaptive case series · Adaptive Randomized Clinical Trial. 于 2026-06-19 检索自 https://scholargate.app/zh/compare