So sánh phương pháp
Xem các phương pháp đã chọn cạnh nhau; những hàng khác biệt được làm nổi bật.
| Thử nghiệm lâm sàng đa trung tâm Giai đoạn III× | Thử nghiệm lâm sàng ngẫu nhiên thích ứng× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | Late 1990s–2000s (widespread adoption post-2010) |
| Người khởi xướng≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| Loại≠ | Confirmatory interventional study design | Experimental clinical trial design |
| Công trình gốc≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Tên gọi khác | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| Liên quan | 6 | 6 |
| Tóm tắt≠ | A multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites. | 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. |
| ScholarGateBộ dữ liệu ↗ |
|
|