Methoden vergleichen

	Adaptive Dosis-Wirkungs-Analyse	Adaptive Randomized Clinical Trial
Fachgebiet	Epidemiologie	Epidemiologie
Familie	Process / pipeline	Process / pipeline
Entstehungsjahr	2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response)	Late 1990s–2000s (widespread adoption post-2010)
Urheber	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
Wegweisende Quelle	Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748.	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
Aliasnamen	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
Verwandt	6	6
Zusammenfassung	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.