Conditional estimation after a two-stage diagnostic biomarker study that allows early termination for futility.
Conditional estimation after a two-stage diagnostic biomarker study that allows early termination for futility.
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DOI：
10.1002/sim.4430
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发表时间：
2012-02-28
影响因子：
2
通讯作者：
Pepe, Margaret Sullivan
中科院分区：
文献类型：
--
作者：
Koopmeiners, Joseph S.;Feng, Ziding;Pepe, Margaret Sullivan
在标记物发现中鉴定的许多生物标记物在验证研究中表现不充分。这促使使用允许因无效而提前终止的成组序贯设计。然而，提前终止的选择将导致达到完全入组的研究的偏倚估计。我们提出了条件估计量和置信区间，纠正这种偏见，假设存在一个未调整的估计量，有一个独立的增量协方差结构。建议的估计量和置信区间适用于条件估计的受试者工作特征（ROC）曲线和阳性预测值（PPV）曲线后，两个阶段的研究，允许提前终止徒劳和他们的性能进行了评估模拟。
Many biomarkers identified in marker discovery are shown to have inadequate performance in validation studies. This motivates the use of group sequential designs that allow early termination for futility. However, an option for early termination will lead to biased estimates for studies that reach full enrollment. We propose conditional estimators and confidence intervals that correct for this bias assuming that an unadjusted estimator exists that has an independent increments covariance structure. The proposed estimators and confidence intervals are applied to conditional estimation of the receiver operating characteristic (ROC) curve and the positive predictive value (PPV) curve after a two-stage study that allows early termination for futility and their performance is evaluated by simulation.
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影响因子：
2.7
作者：
EMERSON, SS;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
1.9
作者：
Tang, Liansheng;Emerson, Scott S.;Zhou, Xiao-Hua
通讯作者：
Zhou, Xiao-Hua
影响因子：
2.7
作者：
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通讯作者：
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影响因子：
3.6
作者：
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通讯作者：
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影响因子：
2.1
作者：
Moskowitz, CS;Pepe, MS
通讯作者：
Pepe, MS