手法を比較

	適応型診断精度研究	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	2000s–2010s (adaptive designs codified for diagnostics ~2010s)	Late 1990s–2000s (widespread adoption post-2010)
提唱者	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
種類	Adaptive observational/experimental study design	Experimental clinical trial design
原典	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.
別名	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
関連	6	6
概要	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.