方法对比

	自适应诊断准确性研究	自适应随机临床试验
领域	流行病学	流行病学
方法族	Process / pipeline	Process / pipeline
起源年份	2000s–2010s (adaptive designs codified for diagnostics ~2010s)	Late 1990s–2000s (widespread adoption post-2010)
提出者	Adaptation of STARD framework (Bossuyt et al.) combined with adaptive design principles (Jennison & Turnbull; FDA guidance)	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
类型	Adaptive observational/experimental study design	Experimental clinical trial design
开创性文献	Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., ... & Cohen, J. F. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527.	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
别名	adaptive DTA study, adaptive diagnostic test evaluation, adaptive test accuracy trial, adaptive STARD study	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
相关	6	6
摘要	An adaptive diagnostic accuracy study evaluates how well an index test distinguishes between patients with and without a target condition, while incorporating pre-specified interim analyses that allow modifications — such as sample size re-estimation, threshold adjustment, or subgroup enrichment — based on accumulating data. This design improves efficiency and ethical conduct compared to fixed-sample diagnostic studies, particularly when prior prevalence or test performance data are uncertain.	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.