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| Thử nghiệm lâm sàng Giai đoạn II theo Bayes× | Thử nghiệm lâm sàng ngẫu nhiên thích ứng× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1990s (Thall & Simon 1994; Berry 1985–2006) | Late 1990s–2000s (widespread adoption post-2010) |
| Người khởi xướng≠ | Peter Thall, Richard Simon, Donald Berry (key contributors) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| Loại≠ | Interventional clinical trial design | Experimental clinical trial design |
| Công trình gốc≠ | Thall, P. F., & Simon, R. (1994). Practical Bayesian guidelines for phase IIB clinical trials. Biometrics, 50(2), 337–349. DOI ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Tên gọi khác | Bayesian phase 2 trial, Bayesian single-arm phase II study, Bayesian early-phase efficacy trial, Bayes phase II | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| Liên quan | 6 | 6 |
| 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. | 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. |
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