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领域临床研究实验设计
方法族Process / pipelineHypothesis test
起源年份1990s-2000s1948
提出者Stephen Pocock, Christopher Jennison, and statistical methodologists; FDA formalized guidance 2019James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
类型Research DesignInterventional comparative study
开创性文献Pocock, S. J. (2005). Current issues in the design and interpretation of clinical trials. BMJ, 330(7500), 1118–1121. link ↗Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗
别名adaptive trial, adaptive design, response-adaptive randomization, RARRCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
相关17
摘要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.A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010).
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ScholarGate方法对比: Adaptive Trial Design · Randomized Controlled Trial. 于 2026-06-18 检索自 https://scholargate.app/zh/compare