國家衛生研究院 NHRI:Item 3990099045/13769
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    题名: Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances
    作者: Wu, YJ;Cheng, YC;Chiang, C;Cheng, LH;Liu, CT;Hsiao, CF
    贡献者: Institute of Population Health Sciences
    摘要: Globalized drug development studies, such as multiregional clinical trials (MRCTs), have attracted much attention due to their ability to expedite drug development and shorten the time lag of drug release. While observing the overall effect of a new drug, the region-specific effects to support drug registration in constituent regions can also be evaluated. Several challenges arise in conducting MRCTs, such as the heterogeneity in the variability of the primary endpoint across regions. However, most of the existing statistical methods assume a common variability, which may not be valid in practice due to differences across regions (eg, diversities in ethnicity or disparities in medical culture/practice). We present a statistical method for the design and evaluation of MRCTs to consider the heterogeneous variability across regions. We assessed the overall sample size requirement and addressed the region-specific sample size determination to establish the consistency of treatment effects between the specific region and the entire group. We demonstrate the proposed approach with numerical examples.
    日期: 2022-01
    關聯: Statistics in Medicine. 2022 Jan 15;41(1):87-107.
    Link to: http://dx.doi.org/10.1002/sim.9224
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0277-6715&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000711476200001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85118197626
    显示于类别:[蕭金福] 期刊論文

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