Two methods for assessing consistency probability in  multiregional clinical trials: a comparison study

Abstract

Abstract:

AIM: To evaluate two methods of consistency assessment in multiregional clinical trials so as to provide a references for the design of multiregional clinical trials. METHODS: R software was applied to compute sample size and consistency probability. RESULTS: By method one, when other parameters were set the same, the required sample size of J region was smaller as the observed treatment effect of J region was better. Compared with the power, the sample size was much more affected by consistency probability. As the size proportion of J region was 10%-50%, the consistency probabilities of method two were higher than method one with two or three regions, and directly opposite with five regions. When four regions are included, the consistency probability of method two is higher than that of method one for the fraction of 10.0%-22.4%. The consistency probability of method two was smaller than that of method one for the fraction of 22.4%-50.0%. CONCLUSION: The sample size of method one is mainly influenced by power, consistency probability and the observed treatment effect for J region. The sample size of method two is also influenced by the number of regions. When method two is used, the number of regions cannot be too much.

Key words: multiregional clinical trial, consistency probability, sample size

CLC Number:

R969

BAI Jianling, CHEN Mengkai, YU Hao, ZHAO Yang, CAI Jingjing, HUANG Lihong, JIANG Zhiwei, CHEN Feng. Two methods for assessing consistency probability in multiregional clinical trials: a comparison study[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(9): 1017-1021.

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Two methods for assessing consistency probability in multiregional clinical trials: a comparison study

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