方法对比

	回顾性II期临床试验	诊断准确性研究设计
领域	流行病学	临床研究
方法族	Process / pipeline	Process / pipeline
起源年份	1980s–1990s (with growth in oncology retrospective analyses)	2003-2015
提出者	Adapted from standard Phase II trial methodology; retrospective variant formalized in oncology practice	Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
类型	Observational retrospective study	Research Design
开创性文献	Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10(1), 1–10.	Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44.
别名	retrospective Phase II study, historical Phase II analysis, retrospective efficacy study, Phase II retrospective analysis	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
相关	5	2
摘要	A retrospective Phase II clinical trial evaluates a treatment's preliminary efficacy and safety signals using existing archival data — medical records, registries, or electronic health records — rather than prospectively enrolling new patients. It mirrors the objectives of a standard Phase II trial (estimating response rate, tolerability, and early efficacy) but does so by looking backward at patients who have already received the intervention, making it faster and less costly than a prospective design.	A diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment.