單組目標值醫療器械臨床試驗設計中，目標值的定義和構建原則是什么

test4

　　與目標值比較的單組設計需事先指定主要評價(jià)指標有臨床意義的目標值，通過(guò)考察單組臨床試驗主要評價(jià)指標的結果是否在指定的目標值范圍內，從而評價(jià)試驗器械有效性/安全性。由于沒(méi)有設置對照組，單組目標值設計的臨床試驗無(wú)法確證試驗器械的優(yōu)效、等效或非劣效，僅能確證試驗器械的有效性/安全性達到專(zhuān)業(yè)領(lǐng)域內公認的最低標準。

　　目標值是專(zhuān)業(yè)領(lǐng)域內公認的某類(lèi)醫療器械的有效性/安全性評價(jià)指標所應達到的最低標準，包括客觀(guān)性能標準（Objective performance criteria，OPC）和性能目標（Performance goal，PG）兩種。目標值通常為二分類(lèi)（如有效/無(wú)效）指標，也可為定量指標，包括靶值和單側置信區間界限（通常為97.5%單側置信區間界限）。對臨床試驗結果進(jìn)行統計分析時(shí)，需計算主要評價(jià)指標的點(diǎn)估計值和單側置信區間界限值，并將其與目標值進(jìn)行比較。

　　目標值的構建通常需要全面收集具有一定質(zhì)量水平及相當數量病例的臨床研究數據，并進(jìn)行科學(xué)分析（如Meta分析）。隨著(zhù)器械技術(shù)和臨床技能的提高，OPC可能發(fā)生改變，需要對臨床數據重新進(jìn)行分析以確認。

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