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领域流行病学流行病学
方法族Process / pipelineProcess / pipeline
起源年份2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response)Late 1990s–2000s (widespread adoption post-2010)
提出者Frank Bretz, José Pinheiro and colleagues; foundational MCP-Mod frameworkDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
类型Adaptive statistical design and analysisExperimental clinical trial design
开创性文献Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748. DOI ↗Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
别名adaptive DRA, adaptive dose-finding analysis, adaptive exposure-response analysis, adaptive D-R modelingadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
相关66
摘要Adaptive dose-response analysis combines pre-specified dose-response modeling with planned interim looks that allow modifications — such as dropping ineffective doses or reallocating sample size — while maintaining statistical integrity. The most widely cited framework is MCP-Mod (Multiple Comparisons and Modeling), endorsed by the EMA and FDA as a fit-for-purpose methodology for dose-finding studies in drug development.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 Dose-Response Analysis · Adaptive Randomized Clinical Trial. 于 2026-06-18 检索自 https://scholargate.app/zh/compare