A pragmatic approach for dynamically incorporating predicate device data in prospective diagnostic test studies

Clinical studies are generally required to characterize the accuracy of new diagnostic tests. In some cases, historical data are available from a predicate device, which is directly relevant to the new test. If this data can be appropriately incorporated into the new test study design, there is an o...

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Veröffentlicht in:Journal of biopharmaceutical statistics 2023-01, Vol.33 (1), p.77-89
Hauptverfasser: Hickey, Graeme L., Parvu, Valentin, Zhang, Yongqiang, Cooper, Charles K., Wan, Ying
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Sprache:eng
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