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多施設共同無作為化臨床試験×適応的無作為化比較試験×
分野疫学疫学
系統Process / pipelineProcess / pipeline
提唱年1970s–1980s (widespread adoption for large-scale efficacy trials)Late 1990s–2000s (widespread adoption post-2010)
提唱者Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980sDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
種類Interventional experimental designExperimental clinical trial design
原典Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
別名multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trialadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
関連66
概要A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.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手法を比較: Multicenter Randomized Clinical Trial · Adaptive Randomized Clinical Trial. 2026-06-18に以下より取得 https://scholargate.app/ja/compare