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| 適応型症例シリーズ× | 適応的無作為化比較試験× | |
|---|---|---|
| 分野 | 疫学 | 疫学 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | Late 20th–early 21st century | Late 1990s–2000s (widespread adoption post-2010) |
| 提唱者≠ | Evolved from classical case series methodology combined with adaptive design principles (Chow & Chang, 2008; FDA adaptive design guidance) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| 種類≠ | Observational study with adaptive monitoring | Experimental clinical trial design |
| 原典≠ | Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887775 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| 別名≠ | adaptive case-series design, sequential adaptive case series, adaptive observational case series | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| 関連≠ | 5 | 6 |
| 概要≠ | An adaptive case series is an observational study design that documents a consecutive group of patients with a shared condition or exposure while incorporating pre-specified rules for modifying data collection, monitoring, or stopping criteria as accumulating evidence warrants. It combines the descriptive richness of traditional case series with the prospective flexibility of adaptive design principles, enabling structured mid-course adjustments without compromising the integrity of the recorded clinical observations. | 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. |
| ScholarGateデータセット ↗ |
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