So sánh phương pháp
Xem các phương pháp đã chọn cạnh nhau; những hàng khác biệt được làm nổi bật.
| Thử nghiệm lâm sàng Giai đoạn II theo Bayes× | Thử nghiệm lâm sàng Giai đoạn II× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1990s (Thall & Simon 1994; Berry 1985–2006) | 1960s–1970s (formalised in US federal drug regulation) |
| Người khởi xướng≠ | Peter Thall, Richard Simon, Donald Berry (key contributors) | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| Loại≠ | Interventional clinical trial design | Interventional clinical study design |
| Công trình gốc≠ | Thall, P. F., & Simon, R. (1994). Practical Bayesian guidelines for phase IIB clinical trials. Biometrics, 50(2), 337–349. DOI ↗ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185392 |
| Tên gọi khác | Bayesian phase 2 trial, Bayesian single-arm phase II study, Bayesian early-phase efficacy trial, Bayes phase II | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept 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. | A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment. |
| ScholarGateBộ dữ liệu ↗ |
|
|