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Design and Data Analysis of Multiregional Clinical Trials (MRCTs)—Theory and Practice

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Biopharmaceutical Applied Statistics Symposium

Part of the book series: ICSA Book Series in Statistics ((ICSABSS))

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Abstract

In recent years, multiregional clinical trial (MRCT) has become a preferred strategy 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 size at the similar level, i.e., without significantly driving up the cost and slowing down the speed of the development.

Chi-Tian Chen, Hsiao-Hui Tsou: These authors contributed equally to this research.

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Author information

Authors and Affiliations

  1. Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, Taiwan, Republic of China

    Chi-Tian Chen, Hsiao-Hui Tsou & Chin-Fu Hsiao

  2. Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung, Taiwan, Republic of China

    Hsiao-Hui Tsou

  3. Institute of Bioinformatics and Structural Biology, National Tsing Hua University, Hsinchu, Taiwan, Republic of China

    Jung-Tzu Liu

  4. Janssen R & D, Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USA

    Fei Chen, Gang Li & K. K. G. Lan

Authors
  1. Chi-Tian Chen
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  2. Hsiao-Hui Tsou
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  3. Jung-Tzu Liu
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  4. Chin-Fu Hsiao
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  5. Fei Chen
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  6. Gang Li
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  7. K. K. G. Lan
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Corresponding authors

Correspondence to Gang Li or K. K. G. Lan .

Editor information

Editors and Affiliations

  1. Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, Georgia, USA

    Karl E. Peace

  2. School of Social Work & Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA

    Ding-Geng Chen

  3. Boston University, Cambridge, Massachusetts, USA

    Sandeep Menon

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© 2018 Springer Nature Singapore Pte Ltd.

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Chen, CT. et al. (2018). Design and Data Analysis of Multiregional Clinical Trials (MRCTs)—Theory and Practice. In: Peace, K., Chen, DG., Menon, S. (eds) Biopharmaceutical Applied Statistics Symposium . ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-7829-3_10

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