統計學術演講公告

統計碩士學位學程將於104年9月29日(星期二)舉辦統計學術演講,

邀請到國家衛生研究院群體健康科學研究所鄒小蕙研究員蒞臨演講,講題為「 Assessing Benefit and Consistency of Treatment Effect under a Discrete Random Effects Model (DREM) in Multiregional Clinical Trials」。

歡迎對於此議題有興趣的師生同仁參加。


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

費用:免費

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 consistency under DREM. We further derive an optimal sample size allocation over regions to maximize the power for consistency. In practice, regional treatment effects are unknown. Thus, we provide some guidelines on the design of MRCTs with consistency when the regional treatment effect are assumed to fall into a specified interval. Numerical examples are given to illustrate the applications of the proposed approach.

活動報名網址:https://info2.ntu.edu.tw/register/flex/main.html?actID=2015C100_02&sesID=1

聯絡人:張仲凱

聯絡方式:E-mail:ntustat@ntu.edu.tw

TEL:(02) 3366-1481 FAX:(02) 3366-1482