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تحلیل تطبیقی پاسخ به دوز×کارآزمایی بالینی فاز II تطبیقی×
حوزهاپیدمیولوژیاپیدمیولوژی
خانوادهProcess / pipelineProcess / pipeline
سال پیدایش2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response)1994 (formal framework); widespread adoption 2000s–2010s
پدیدآورFrank Bretz, José Pinheiro and colleagues; foundational MCP-Mod frameworkPeter Bauer & Klaus Kohne (formal statistical framework, 1994); broader adaptive trial methodology developed through FDA and ICH guidance in the 2000s
نوعAdaptive statistical design and analysisExperimental clinical trial design
منبع بنیادینBretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748. DOI ↗Bauer, P., & Kohne, K. (1994). Evaluation of experiments with adaptive interim analyses. Biometrics, 50(4), 1029–1041. DOI ↗
نام‌های دیگرadaptive DRA, adaptive dose-finding analysis, adaptive exposure-response analysis, adaptive D-R modelingAdaptive Ph II trial, seamless adaptive Phase II, adaptive dose-finding trial, response-adaptive Phase II
مرتبط61
خلاصهAdaptive 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 Phase II clinical trial is a prospective experimental design in which pre-specified rules allow the study protocol to be modified — such as dropping arms, adjusting sample size, or narrowing the patient population — based on accumulating interim data, without inflating the Type I error rate. The design is widely used in early-phase drug development to screen candidate doses or treatments efficiently while preserving statistical validity.
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ScholarGateمقایسهٔ روش‌ها: Adaptive Dose-Response Analysis · Adaptive Phase II Clinical Trial. بازیابی‌شده در 2026-06-19 از https://scholargate.app/fa/compare