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| 순차/그룹 순차 시험 설계× | Randomized Controlled Trial (RCT)× | |
|---|---|---|
| 분야 | 실험설계 | 실험설계 |
| 계열 | Hypothesis test | Hypothesis test |
| 기원 연도≠ | 1979 | 1948 |
| 창시자≠ | O'Brien & Fleming; Pocock; Lan & DeMets | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| 유형≠ | Adaptive stopping trial design | Interventional comparative study |
| 원전≠ | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ | 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 ↗ |
| 별칭≠ | group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential) | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| 관련≠ | 3 | 7 |
| 요약≠ | Sequential and group sequential trial designs allow a study to be stopped early — or continued — based on interim analyses conducted as data accumulate. The core framework was formalised by O'Brien and Fleming in 1979 and extended by Lan and DeMets's alpha-spending approach, and it controls the overall Type I error rate across all planned looks by pre-specifying both efficacy and futility boundaries before enrolment begins. | 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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