講 題:What will ICH E17 impact on MRCT?         
                          主講人:蕭金福 研究員兼副所長(國家衛生研究院群體健康科學研究所)
                          時 間:2019年3月7日(星期四)下午02:10 - 04:00
                          地 點:B302A(淡水校園商管大樓)
                          茶 會:2019 年 3 月 7 日(星期四)下午01:30(商管大樓B1102)
  
 摘 要
 
 
Recently, global drug development has attracted much attention from pharmaceutical companies. Unlike traditional clinical trials, the design of multiregional clinical trial (MRCT) recruiting subjects from many countries around the world under the same protocol has led to a new strategy for drug development. This kind of design has been widely adopted by global pharmaceutical companies, which seek simultaneous drug development, submission, and regulatory approval throughout key world markets to hasten the market availability of the drug, as well as improved patient access to new and innovative treatments. However, a key issue for conducting MRCTs is how to demonstrate the efficacy of a drug in all participating regions while also evaluating the possibility of applying the overall trial results to each region. The idea of an MRCT was first raised in the 11th Q&A of ICH E5. To establish a framework for how to demonstrate the efficacy of a drug in all participating regions while also evaluating the possibility of applying the overall trial results to each region by conducting an MRCT, the ICH released the E17 guideline “General principle on planning/designing Multi-Regional Clinical Trials” in 2017 to describe general principles for the planning and the design of MRCTs.
 

        In this presentation, we will discuss some practical issues raised by ICH E17 and how Taiwan implement ICH E17 for drug evaluation.


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更新日期 : 2024/05/27