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| Адаптивно клинично изпитване Фаза III× | Адаптивно рандомизирано клинично изпитване× | |
|---|---|---|
| Област | Епидемиология | Епидемиология |
| Семейство | Process / pipeline | Process / pipeline |
| Година на възникване≠ | 1969–2019 (sequential testing roots ~1969; formal adaptive design guidance 2010–2019) | Late 1990s–2000s (widespread adoption post-2010) |
| Създател≠ | Methodological foundations by Armitage et al. (1969); modern adaptive framework codified by FDA and ICH guidance (2010s) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| Тип≠ | Interventional confirmatory clinical trial with pre-specified interim adaptations | Experimental clinical trial design |
| Основополагащ източник≠ | 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 ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Други названия | adaptive confirmatory trial, seamless Phase II/III adaptive trial, adaptive pivotal trial, adaptive design Phase III | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| Свързани | 6 | 6 |
| Резюме≠ | 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. | 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. |
| ScholarGateНабор от данни ↗ |
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