國家衛生研究院 NHRI:Item 3990099045/4883
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/4883


    Title: Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials - Asian perspective
    Authors: Tsou, HH;Chow, SC;Lan, KK;Liu, JP;Wang, M;Chern, HD;Ho, LT;Hsiung, CA;Hsiao, CF
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and to shorten approval time, the design of multi-regional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Recently, the trend for simultaneous clinical development in Asian countries being undertaken simultaneously with clinical trials conducted in Europe and the United States has been rapidly rising. In this paper, proposals of statistical consideration to multi-regional trials are provided. More specifically, three aspects are addressed: the definition of the 'Asian region,' the consistency criterion between the 'Asian region' and the overall regions, and the sample size determination for the multi-regional trial.
    Date: 2010-07
    Relation: Pharmaceutical Statistics. 2010 Jul;9(3):201-206.
    Link to: http://dx.doi.org/10.1002/pst.442
    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:000282918300005
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=77957365760
    Appears in Collections:[Chin-Fu Hsiao] Periodical Articles
    [Hsiao-Hui Sophie Tsou] Periodical Articles
    [Jen-Pei Liu(1998-2002)] Periodical Articles
    [Chao A. Hsiung] Periodical Articles

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