國家衛生研究院 NHRI:Item 3990099045/11593
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    題名: Design and data analysis of multiregional clinical trials (MRCTs)—Theory and practice
    作者: Chen, CT;Tsou, HH;Liu, JT;Hsiao, CF;Chen, F;Li, G;Lan, KKG
    貢獻者: Institute of Population Health Sciences
    摘要: In recent years, multiregional clinical trial (MRCT)Multiregional clinical trial (MRCT)has become a preferredPreferred termsstrategy to develop new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs could speed up the patient enrollment, thus resulted in a quicker drug development and obtain faster approval of the drug globally. At the same time, the MRCT strategy is expected to maintain the sample sizeSample sizeat the similar level, i.e., without significantly driving up the cost and slowing down the speed of the development.
    日期: 2018-08-21
    關聯: Biopharmaceutical Applied Statistics Symposium : Design of Clinical Trials. 2018 Aug 21;Chapter 10:269-286.
    Link to: http://dx.doi.org/10.1007/978-981-10-7829-3_10
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