國家衛生研究院 NHRI:Item 3990099045/1783
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    题名: A two-stage design for bridging studies
    作者: Hsiao, CF;Xu, JZ;Liu, JP
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: The ICH E5 guideline defines a bridging study as a supplementary study conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. Therefore, a bridging study is usually conducted in the new region only after the test product has been approved for commercial marketing in the original region based on its proven efficacy and safety. One of the current issues for evaluation of bridging studies is a cross-study comparison. Therefore, bias occurs when the study is not internally valid. A two-stage approach is proposed to overcome the issue of internal validity and at the same time to meet the objective of minimizing unnecessary duplication of clinical data required by the ICH E5 guideline. Under the framework of the proposed two- stage design, the bridging study of the new region is a second-stage substudy of the whole trial, and the patients for the bridging substudy are enrolled only after the data obtained in the original region demonstrate a statistically significantly positive treatment effect. Methods for the determination of the sample size for each region and the critical values at each stage are also proposed.
    关键词: Pharmacology & Pharmacy;Statistics & Probability
    日期: 2005
    關聯: Journal of Biopharmaceutical Statistics. 2005;15(1):75-83.
    Link to: http://dx.doi.org/10.1081/BIP-200040836
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000236207800007
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=12344263150
    显示于类别:[劉仁沛(1998-2002)] 期刊論文
    [蕭金福] 期刊論文

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