場次內容
講題:Assessing Benefit and Consistency of Treatment Effect under a Discrete Random Effects Model (DREM) in Multiregional Clinical Trials
講員:鄒小蕙研究員 國家衛生研究院群體健康科學研究所
時間:2015年9月29日星期二 下午 3:00 ~ 5:00
地點:臺灣大學博雅教學館405講堂
名額:40位
摘要:
In recent years, developing pharmaceutical products via a multiregional clinical trial (MRCT) has become standard. Traditionally, an MRCT would assume a fixed treatment effect across regions. However, heterogeneity among regions may have impact upon the evaluation of a medicine’s effect. In this study, we consider a random effects model using discrete priors (DREM) to account for heterogeneous treatment effects across regions for the design and evaluation of MRCTs. We derive power for a treatment is beneficial under DREM and illustrate determination of the overall sample size in an MRCT. We use the concept of consistency based on Method 2 of the Japanese Ministry of Health, Labour and Welfare guidance to evaluate the probability for treatment benefit and