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| 점증적 용량 설계 (지속적 재평가 방법)× | 순차/그룹 순차 시험 설계× | |
|---|---|---|
| 분야 | 실험설계 | 실험설계 |
| 계열≠ | Process / pipeline | Hypothesis test |
| 기원 연도≠ | 1990 | 1979 |
| 창시자≠ | John O'Quigley, Margaret Pepe & Lloyd Fisher | O'Brien & Fleming; Pocock; Lan & DeMets |
| 유형≠ | Adaptive Bayesian dose-finding design | Adaptive stopping trial design |
| 원전≠ | O'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48. DOI ↗ | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ |
| 별칭≠ | Continual Reassessment Method, CRM Design, Phase I Dose-Finding Design, Doz Artırma Tasarımı | group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential) |
| 관련≠ | 2 | 3 |
| 요약≠ | Dose-Escalation Design, formalized as the Continual Reassessment Method (CRM), is a Bayesian adaptive algorithm for identifying the Maximum Tolerated Dose (MTD) in Phase I clinical trials. Introduced by John O'Quigley, Margaret Pepe, and Lloyd Fisher in 1990, CRM treats dose-toxicity response as a parametric curve, updates a prior probability model after each patient's outcome, and assigns subsequent patients to the dose currently estimated closest to a pre-specified target toxicity probability. | 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. |
| ScholarGate데이터셋 ↗ |
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