方法对比

	自适应剂量-反应分析	筛查试验评估
领域	流行病学	流行病学
方法族	Process / pipeline	Process / pipeline
起源年份	2000s (key papers 2005–2007; ICH E4 guidance 1994 for classical dose-response)	1968 (Wilson-Jungner principles); statistical framework developed 1970s–2000s
提出者	Frank Bretz, José Pinheiro and colleagues; foundational MCP-Mod framework	Wilson & Jungner (WHO criteria, 1968); foundational work by Pepe, Altman, and others in statistical test evaluation
类型	Adaptive statistical design and analysis	Observational diagnostic / epidemiological evaluation design
开创性文献	Bretz, F., Pinheiro, J. C., & Branson, M. (2005). Combining multiple comparisons and modeling techniques in dose-response studies. Biometrics, 61(3), 738-748.	Wilson, J. M. G., & Jungner, G. (1968). Principles and Practice of Screening for Disease. World Health Organization. Public Health Papers No. 34.
别名	adaptive DRA, adaptive dose-finding analysis, adaptive exposure-response analysis, adaptive D-R modeling	screening study, screening performance evaluation, screening accuracy assessment, STE
相关	6	6
摘要	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.	Screening test evaluation is a systematic epidemiological approach for assessing whether a test or program can accurately and cost-effectively identify individuals with a condition before symptoms appear. It quantifies diagnostic performance metrics — sensitivity, specificity, predictive values, and the ROC curve — and evaluates whether a screening program meets established public health criteria for adoption and harm-benefit balance.