場次內容
講題:Statistical Methodologies to Design and Evaluation of Multi-regional Clinical Trials
講者:蕭金福 博士 國家衛生研究院群體健康科學研究所研究員
時間:2014年11月21日星期五 上午10:30 ~ 12:00
地點:臺灣大學博雅教學館405講堂
名額:40位
摘要:
To accelerate the drug 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 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. In this talk we focus on a specific region and establish four statistical criteria to assess the consistency between the specific region and overall results in a MRCT. More specifically, 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