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적응형 시험 설계×Randomized Controlled Trial (RCT)×
분야임상연구실험설계
계열Process / pipelineHypothesis test
기원 연도1990s-2000s1948
창시자Stephen Pocock, Christopher Jennison, and statistical methodologists; FDA formalized guidance 2019James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
유형Research DesignInterventional comparative study
원전Pocock, 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 ↗
별칭adaptive trial, adaptive design, response-adaptive randomization, RARRCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
관련17
요약An 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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