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| Thiết kế thử nghiệm lâm sàng Giai đoạn III thích ứng× | Thử nghiệm lâm sàng ngẫu nhiên (RCT)× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1969–2019 (sequential testing roots ~1969; formal adaptive design guidance 2010–2019) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Người khởi xướng≠ | Methodological foundations by Armitage et al. (1969); modern adaptive framework codified by FDA and ICH guidance (2010s) | Austin Bradford Hill; MRC Streptomycin Trial team |
| Loại≠ | Interventional confirmatory clinical trial with pre-specified interim adaptations | Interventional experimental study |
| Công trình gốc≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2019). ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials. ICH Harmonised Guideline. link ↗ | 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 |
| Tên gọi khác | adaptive confirmatory trial, seamless Phase II/III adaptive trial, adaptive pivotal trial, adaptive design Phase III | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Liên quan | 6 | 6 |
| Tóm tắt≠ | An adaptive Phase III clinical trial is a confirmatory randomized controlled trial that incorporates pre-specified rules allowing modifications to the trial design — such as sample size re-estimation, dose selection, or population enrichment — based on accumulating interim data, while preserving the Type I error rate. It sits at the top of the evidence hierarchy and is used to obtain regulatory approval of new interventions. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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