手法を比較
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| ベイズ型第I相臨床試験× | 適応的無作為化比較試験× | |
|---|---|---|
| 分野 | 疫学 | 疫学 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 1990 | Late 1990s–2000s (widespread adoption post-2010) |
| 提唱者≠ | O'Quigley, Pepe & Fisher (Continual Reassessment Method) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| 種類≠ | Adaptive Bayesian dose-finding design | Experimental clinical trial design |
| 原典≠ | 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 ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| 別名 | Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| 関連≠ | 5 | 6 |
| 概要≠ | A Bayesian Phase I clinical trial uses prior probability models and sequential Bayes updating to find the maximum tolerated dose (MTD) of a new agent. Unlike the traditional 3+3 rule-based escalation, the Bayesian approach revises a dose-toxicity curve continuously as each patient's outcome is observed, allowing faster convergence to the true MTD while minimising exposure of patients to unsafe or subtherapeutic doses. | An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study. |
| ScholarGateデータセット ↗ |
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