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適応的試験デザイン×生存時間解析×
分野臨床研究研究統計
系統Process / pipelineProcess / pipeline
提唱年1990s-2000s1958
提唱者Stephen Pocock, Christopher Jennison, and statistical methodologists; FDA formalized guidance 2019Edward L. Kaplan and Paul Meier
種類Research DesignMethod
原典Pocock, S. J. (2005). Current issues in the design and interpretation of clinical trials. BMJ, 330(7500), 1118–1121. link ↗Kaplan, E. L., & Meier, P. (1958). Nonparametric estimation from incomplete observations. Journal of the American Statistical Association, 53(282), 457–481. DOI ↗
別名adaptive trial, adaptive design, response-adaptive randomization, RARKaplan-Meier analysis, Cox regression, TTE analysis
関連13
概要An adaptive trial design allows pre-specified modifications to the trial based on interim data—such as sample size re-estimation, stopping for futility or efficacy, dropping ineffective arms, or shifting randomization ratios toward better-performing treatments. Developed systematically in the 1990s–2000s by statisticians like Pocock and Jennison, and formalized by the FDA in 2019, adaptive designs accelerate drug development, reduce exposure to ineffective treatments, and improve efficiency without inflating false-positive rates when properly executed.Survival analysis is a collection of statistical methods for modeling time from a defined starting point until an event of interest occurs (disease, recovery, death, equipment failure). Kaplan and Meier's nonparametric estimator (1958) and David Cox's proportional hazards model (1972) jointly enabled analysis of censored data—individuals whose event times are unknown because they left the study or were still event-free at follow-up. Indispensable in oncology, cardiology, infectious disease research, engineering reliability, and any field where time-to-event matters.
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ScholarGate手法を比較: Adaptive Trial Design · Survival Analysis. 2026-06-18に以下より取得 https://scholargate.app/ja/compare