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Proposals of statistical consideration to evaluation of results for a specific region in multi‐regional trials – Asian perspective
Author(s) -
Tsou HsiaoHui,
Chow SheinChung,
Lan K. K. Gordon,
Liu Jenpei,
Wang Mey,
Chern HerngDer,
Ho LowTone,
Hsiung Chao A.,
Hsiao ChinFu
Publication year - 2010
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.442
Subject(s) - clinical trial , drug development , consistency (knowledge bases) , protocol (science) , drug trial , perspective (graphical) , sample size determination , sample (material) , process (computing) , computer science , medicine , regional science , geography , statistics , alternative medicine , drug , artificial intelligence , mathematics , pharmacology , chemistry , pathology , chromatography , operating system
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. Copyright © 2010 John Wiley & Sons, Ltd.