ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Scientific guideline
Table of contents
The purpose of this document is to outline general principles for the planning and design of multiregional clinical trials with the aim of increasing their acceptability in global regulatory submissions. The document addresses some strategic programme issues as well as aspects specific to the planning and design of confirmatory MRCTs and should be used together with other ICH efficacy guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.
Keywords: MRCT , multiregional, clinical trials, confirmatory trials, exploratory trials
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ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version (PDF/466.31 KB)
Adopted
First published: 18/12/2017
Last updated: 18/12/2017
Legal effective date: 14/06/2018
EMA/CHMP/ICH/453276/2016 -
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Overview of comments received by EMA on 'Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b' - First version (PDF/260.01 KB)
First published: 13/02/2017
Last updated: 13/02/2017
EMA/605292/2017 -
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Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b - First version (PDF/428.91 KB)
Draft: consultation closed
First published: 28/07/2016
Last updated: 22/09/2016
Consultation dates: 28/07/2016 to 28/01/2017
EMA/CHMP/ICH/453276/2016