Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials

Abstract Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate considerations regarding...

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Bibliographic Details
Published in:Contemporary clinical trials 2017-07, Vol.58, p.13-22
Main Authors: Quan, Hui, Mao, Xuezhou, Tanaka, Yoko, Binkowitz, Bruce, Li, Gang, Chen, Josh, Zhang, Ji, Zhao, Peng-Liang, Ouyang, Soo Peter, Chang, Mark
Format: Article
Language:English
Subjects:
Between-region variability
Cardiovascular
Clinical Studies as Topic - methods
Clinical Studies as Topic - standards
Consistency of treatment effects
Continental Population Groups
Equivalence Trials as Topic
Fixed and random effects models
Hematology, Oncology and Palliative Medicine
Humans
Models, Statistical
Multicenter Studies as Topic - methods
Multicenter Studies as Topic - standards
Practice Patterns, Physicians
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - standards
Reproducibility of Results
Residence Characteristics - statistics & numerical data
Sample size
Shrinkage estimate
Time Factors
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Summary:Abstract Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate considerations regarding design, conduct, analysis and interpretation of result of MRCTs. We start with a brief discussion of region definitions and the scenarios where different regions have differing requirements for a MRCT. We then compare different designs and models as well as the corresponding interpretation of the results. We highlight the importance of paying special attention to trial monitoring and conduct to prevent potential issues associated with the final trial results. Besides evaluating the overall treatment effect for the entire MRCT, we also consider other key analyses including quantification of regional treatment effects within a MRCT, and assessment of consistency of these regional treatment effects.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2017.04.009