淡江大學數學系演講公告

主 講 人：蕭金福 副研究員
        國家衛生研究院 群體健康科學研究所 生物統計與生物資訊研究組
講   題： Design and Evaluation in Multi-regional Clinical Trials
日    期：99年12月07日（星期二）
時    間：下午2:30–3:20
地    點：數學系(科學館S433室)
摘    要：
To speed up drug development to allow faster access to medicines for patients 
globally, conducting multi-regional trials incorporating subjects from many 
countries around the world under the same protocol may be desired. In this 
paper, we focus on a specific region and establish statistical criteria for 
consistency between the region of interest and overall results. More 
specifically, four criteria are considered. Two criteria are to assess whether the 
treatment effect in the region of interest is as large as that of the other regions or 
of the regions overall, while the other two criteria are to assess the consistency 
of the treatment effect of the specific region with other regions or the regions 
overall. Sample size required for the region of interest can also be evaluated 
based on these four criteria. However, in practice, it might be expected that 
there is a difference in treatment effect due to regional difference (e.g., ethnic 
difference). Therefore, a random effect model for heterogeneous treatment effect 
across regions is also proposed for the design and evaluation of multi-regional 
trials. We also address consideration on the determination of the number of 
subjects in a specific region to establish the consistency of treatment effects 
between the specific region and the entire group.           


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