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Abstract:
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Multi-regional clinical trials (MRCT) included as part of a regulatory submission have been widely conducted in both ICH and non-ICH regions. In order to harmonize points to consider while minimizing the conflicting opinions surrounding conduct of such MRCTs, an ICH working group was established in late 2014 to create an international guideline for MRCTs. This guideline is known as ICH E17, was issued in 2Q2016 and focuses on general principles for the planning and design of MRCTs with the goal of encouraging the use of MRCTs. The ICH working group desired a broad audience for the guidance, writing in a less technical manner but there are plenty of relevant and important topics for statisticians. This contributed panel session will bring together members of the ICH group, plus others from regulatory, academia and industry. This session will focus on two topics: 1) The objective/scope of the ICH E17 guidance, discussion of the public comments, and the regional implementation as well as the basic principles of MRCT; 2) Key statistical considerations in MRCT including methodology not necessarily mentioned in ICH E17. The audience will have an opportunity to ask questions.
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