方法对比
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| 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≠ | 1960s–1970s (formalised in US federal drug regulation) | 2003-2015 |
| 提出者≠ | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) | Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers |
| 类型≠ | Interventional clinical study design | Research Design |
| 开创性文献≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185392 | 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. DOI ↗ |
| 别名 | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial | diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation |
| 相关≠ | 6 | 2 |
| 摘要≠ | A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment. | 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. |
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