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| Adaptive Diagnostic Accuracy Study× | Adaptive Randomized Clinical Trial× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 2000s–2010s (adaptive designs codified for diagnostics ~2010s) | Late 1990s–2000s (widespread adoption post-2010) |
| Urheber≠ | 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 |
| Typ≠ | Adaptive observational/experimental study design | Experimental clinical trial design |
| Wegweisende Quelle≠ | 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. DOI ↗ | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Aliasnamen | 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 |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | 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. |
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