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| 베이지안 임상 3상 시험× | 순차 분석 (그룹 순차 설계)× | |
|---|---|---|
| 분야≠ | 역학 | 통계학 |
| 계열≠ | Process / pipeline | Hypothesis test |
| 기원 연도≠ | 1990s–2000s (widespread application) | 1977 |
| 창시자≠ | Donald A. Berry; David J. Spiegelhalter (formalization in clinical context) | P. C. O'Brien & T. R. Fleming; P. C. Pocock |
| 유형≠ | Confirmatory randomized controlled trial with Bayesian inference | Sequential / adaptive hypothesis test |
| 원전≠ | Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. ISBN: 978-0471499756 | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ |
| 별칭 | Bayesian confirmatory trial, Bayesian RCT Phase III, Bayesian pivotal trial, BayesCT | sequential testing, group sequential design, interim analysis, Sıralı Analiz (Sequential Testing / Group Sequential Design) |
| 관련 | 5 | 5 |
| 요약≠ | A Bayesian Phase III clinical trial is a large-scale, confirmatory randomized controlled trial that uses Bayesian statistical inference rather than conventional frequentist hypothesis testing to evaluate whether an experimental treatment meets pre-defined efficacy and safety thresholds. By combining prior evidence with accumulating trial data, it quantifies the probability that the treatment effect exceeds a clinically meaningful threshold, enabling more transparent decision-making under uncertainty. | Sequential analysis is a framework for conducting hypothesis tests with pre-planned interim looks at accumulating data, allowing a study to stop early for efficacy or futility while controlling the overall Type I error rate. The group sequential approach was formalised by Pocock (1977) and O'Brien and Fleming (1979), and remains the standard for confirmatory clinical trials and rigorous A/B experiments. |
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