國家衛生研究院 NHRI:Item 3990099045/4047
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/4047


    Title: Inference on treatment effects for targeted clinical trials under enrichment design
    Authors: Liu, JP;Lin Jr, R;Chow, SC
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: After completion of a human genome project, the disease targets at molecular level can be identified. As a result, treatment modality for molecular targets can be developed. In practice, targeted clinical trials are usually conducted for evaluation of the possibility and feasibility of the individualized treatment of patients. However, the accuracy of diagnostic devices for identification of such molecular targets is usually not perfect. Therefore, some of the patients enrolled in targeted clinical trials with a positive result by the diagnostic device might not have the specific molecular targets and hence the treatment effects of the targeted drugs estimated from targeted clinical trials could be biased for the patient population truly with the molecular targets. Under an enrichment design for targeted clinical trials, we propose to use the EM algorithm and bootstrap method for obtaining the inference of the treatment effects of the targeted drugs in the patient population truly with molecular targets. A simulation study was conducted to empirically investigate the bias and variability of the proposed estimator and the size and power of the proposed testing method. Simulation results demonstrate that the proposed estimator is unbiased with adequate precision and the confidence interval can provide satisfactory coverage probability. In addition, the proposed testing procedure can adequately control the size with sufficient power. A practical example illustrates the utility of the proposed method.
    Date: 2009-10
    Relation: Pharmaceutical Statistics. 2009 Oct;8(4):356-370.
    Link to: http://dx.doi.org/10.1002/pst.364
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1539-1604&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000273369000009
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=73949142341
    Appears in Collections:[Jen-Pei Liu(1998-2002)] Periodical Articles

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