Porovnat metody
Prohlédněte si vybrané metody vedle sebe; řádky, které se liší, jsou zvýrazněny.
| Analýza adaptivní dávkové odpovědi× | Adaptivní randomizovaná klinická studie× | |
|---|---|---|
| Obor | Epidemiologie | Epidemiologie |
| Rodina | Process / pipeline | Process / pipeline |
| Rok vzniku≠ | 2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response) | Late 1990s–2000s (widespread adoption post-2010) |
| Tvůrce≠ | Frank Bretz, José Pinheiro and colleagues; foundational MCP-Mod framework | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| Typ≠ | Adaptive statistical design and analysis | Experimental clinical trial design |
| Původní zdroj≠ | Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748. DOI ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Další názvy | adaptive DRA, adaptive dose-finding analysis, adaptive exposure-response analysis, adaptive D-R modeling | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| Příbuzné | 6 | 6 |
| Shrnutí≠ | Adaptive dose-response analysis combines pre-specified dose-response modeling with planned interim looks that allow modifications — such as dropping ineffective doses or reallocating sample size — while maintaining statistical integrity. The most widely cited framework is MCP-Mod (Multiple Comparisons and Modeling), endorsed by the EMA and FDA as a fit-for-purpose methodology for dose-finding studies in drug development. | 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. |
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