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| Thử nghiệm lâm sàng Giai đoạn II theo Bayes× | Thiết kế Tìm Liều Giai đoạn I Lâm sàng theo Bayes× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1990s (Thall & Simon 1994; Berry 1985–2006) | 1990 |
| Người khởi xướng≠ | Peter Thall, Richard Simon, Donald Berry (key contributors) | O'Quigley, Pepe & Fisher (Continual Reassessment Method) |
| Loại≠ | Interventional clinical trial design | Adaptive Bayesian dose-finding design |
| Công trình gốc≠ | Thall, P. F., & Simon, R. (1994). Practical Bayesian guidelines for phase IIB clinical trials. Biometrics, 50(2), 337–349. DOI ↗ | 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 ↗ |
| Tên gọi khác | Bayesian phase 2 trial, Bayesian single-arm phase II study, Bayesian early-phase efficacy trial, Bayes phase II | Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study |
| Liên quan≠ | 6 | 5 |
| Tóm tắt≠ | A Bayesian Phase II clinical trial applies Bayesian statistical inference to the standard Phase II objective of evaluating whether an experimental treatment shows sufficient early-phase efficacy to justify progression to a Phase III trial. By combining prior information with accumulating trial data, it enables principled interim monitoring, flexible stopping rules, and updated probability statements about treatment effect — all without the multiple-testing penalties that burden frequentist sequential designs. | 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. |
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