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Establishing consistency across all regions in a multi‐regional clinical trial
Author(s) -
Tsou HsiaoHui,
James Hung H. M.,
Chen YueMing,
Huang WongShian,
Chang Wanjung,
Hsiao ChinFu
Publication year - 2012
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.1512
Subject(s) - consistency (knowledge bases) , christian ministry , computer science , clinical trial , process (computing) , protocol (science) , sample (material) , operations research , econometrics , risk analysis (engineering) , medicine , mathematics , artificial intelligence , alternative medicine , political science , pathology , chromatography , law , operating system , chemistry
In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and shorten approval time, the design of multi‐regional clinical trials (MRCTs) incorporates subjects from many countries/regions around the world under the same protocol. After showing the overall efficacy of a drug in a global trial, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each region. However, most of the recent approaches developed for the design and evaluation of MRCTs focus on establishing criteria to examine whether the overall results from the MRCT can be applied to a specific region. In this paper, we use the consistency criterion of Method 1 from the Japanese Ministry of Health, Labour and Welfare (MHLW) guidance to assess whether the overall results from the MRCT can be applied to all regions. Sample size determination for the MRCT is also provided to take all the consistency criteria from each individual region into account. Numerical examples are given to illustrate applications of the proposed approach. Copyright © 2012 John Wiley & Sons, Ltd.